Adverse Events Report for NCT03640312 - XML Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
: Adverse Events Report for NCT03640312 - XML Representation

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  <id value="370505"/>
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    <lastUpdated value="2025-08-18T13:22:42.074Z"/>
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    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 370505</b></p><a name="370505"> </a><a name="hc370505"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 25; Last updated: 2025-08-18 13:22:42+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-outcome-measure-report.html">OutcomeMeasureReport</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}">Active</span></p><p><b>url</b>: <a href="https://fevir.net/resources/Composition/370505">https://fevir.net/resources/Composition/370505</a></p><p><b>identifier</b>: FEvIR Object Identifier/370505, FEvIR Linking Identifier/NCT03640312-adverse-events-report</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 OutcomeMeasureReport}">Outcome Measure Report</span></p><p><b>date</b>: 2025-08-18 13:22:42+0000</p><p><b>author</b>: [No author listed.]</p><p><b>title</b>: Adverse Events Report for NCT03640312</p><p><b>custodian</b>: <a href="Organization-118079.html">Computable Publishing LLC</a></p><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style="display: none">*</td><td>Cite As</td><td><div><p>Adverse Events Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370505. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370505. Computable resource at: https://fevir.net/FLI/DocumentForComposition370505.</p>
</div></td></tr></table><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-AllCauseMortality</b></p><a name="370505/NCT03640312-AllCauseMortality"> </a><a name="hc370505/NCT03640312-AllCauseMortality"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: All-cause mortality (timeframe for NCT03640312)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">All-cause mortality</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvents</b></p><a name="370505/NCT03640312-SeriousAdverseEvents"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvents"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Serious Adverse Events (timeframe for NCT03640312)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Serious Adverse Events</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvents</b></p><a name="370505/NCT03640312-OtherAdverseEvents"> </a><a name="hc370505/NCT03640312-OtherAdverseEvents"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Other Adverse Events (timeframe for NCT03640312)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Other Adverse Events</span></td></tr></table><p><b>handling</b>: boolean variable</p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-AllCauseMortality-EG000</b></p><a name="370505/NCT03640312-AllCauseMortality-EG000"> </a><a name="hc370505/NCT03640312-AllCauseMortality-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_AllCauseMortality_EG000</p><p><b>title</b>: All-cause mortality for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-AllCauseMortality">EvidenceVariable All-cause mortality (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG000</b></p><a name="370505/NCT03640312-SeriousAdverseEvents-EG000"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvents-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvents_EG000</p><p><b>title</b>: Serious Adverse Events for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvents">EvidenceVariable Serious Adverse Events (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0625</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvents-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvents-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvents_EG000</p><p><b>title</b>: Other Adverse Events for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvents">EvidenceVariable Other Adverse Events (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.625</p><p><b>numberAffected</b>: 20</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-AllCauseMortality-EG001</b></p><a name="370505/NCT03640312-AllCauseMortality-EG001"> </a><a name="hc370505/NCT03640312-AllCauseMortality-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_AllCauseMortality_EG001</p><p><b>title</b>: All-cause mortality for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-AllCauseMortality">EvidenceVariable All-cause mortality (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG001</b></p><a name="370505/NCT03640312-SeriousAdverseEvents-EG001"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvents-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvents_EG001</p><p><b>title</b>: Serious Adverse Events for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvents">EvidenceVariable Serious Adverse Events (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvents-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvents-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvents_EG001</p><p><b>title</b>: Other Adverse Events for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvents">EvidenceVariable Other Adverse Events (timeframe for NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.4666666666666667</p><p><b>numberAffected</b>: 14</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG000</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-0-EG000"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-0-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvent_0_EG000</p><p><b>title</b>: Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvent-0">EvidenceVariable Road Traffic Accident as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG001</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-0-EG001"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-0-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvent_0_EG001</p><p><b>title</b>: Road Traffic Accident as serious adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvent-0">EvidenceVariable Road Traffic Accident as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-0</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-0"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-0"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Road Traffic Accident as serious adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Road Traffic Accident as serious adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Serious Adverse Event</span>, <span title="Codes:">Injury, poisoning and procedural complications</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG000</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-1-EG000"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-1-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvent_1_EG000</p><p><b>title</b>: Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvent-1">EvidenceVariable Chest Pain as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG001</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-1-EG001"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-1-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_SeriousAdverseEvent_1_EG001</p><p><b>title</b>: Chest Pain as serious adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-SeriousAdverseEvent-1">EvidenceVariable Chest Pain as serious adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-1</b></p><a name="370505/NCT03640312-SeriousAdverseEvent-1"> </a><a name="hc370505/NCT03640312-SeriousAdverseEvent-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Chest Pain as serious adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Chest Pain as serious adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Serious Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-0-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-0-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_0_EG000</p><p><b>title</b>: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-0">EvidenceVariable Vision blurred as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-0-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-0-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_0_EG001</p><p><b>title</b>: Vision blurred as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-0">EvidenceVariable Vision blurred as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-0</b></p><a name="370505/NCT03640312-OtherAdverseEvent-0"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-0"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Vision blurred as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>2 Total events:</p>
<ol>
<li>Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan</li>
<li>Severe, resolved without sequelae, unlikely related, no action taken, LDQT</li>
</ol>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Vision blurred as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Eye disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-1-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-1-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_1_EG000</p><p><b>title</b>: Palpitations as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-1">EvidenceVariable Palpitations as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-1-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-1-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_1_EG001</p><p><b>title</b>: Palpitations as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-1">EvidenceVariable Palpitations as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-1</b></p><a name="370505/NCT03640312-OtherAdverseEvent-1"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Palpitations as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Palpitations as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Cardiac disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-2-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-2-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_2_EG000</p><p><b>title</b>: Tinnitus as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-2">EvidenceVariable Tinnitus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-2-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-2-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_2_EG001</p><p><b>title</b>: Tinnitus as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-2">EvidenceVariable Tinnitus as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-2</b></p><a name="370505/NCT03640312-OtherAdverseEvent-2"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-2"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Tinnitus as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Tinnitus as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Ear and labyrinth disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-3-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-3-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_3_EG000</p><p><b>title</b>: Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-3">EvidenceVariable Eye pruritis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-3-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-3-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_3_EG001</p><p><b>title</b>: Eye pruritis as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-3">EvidenceVariable Eye pruritis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-3</b></p><a name="370505/NCT03640312-OtherAdverseEvent-3"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-3"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Eye pruritis as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Eye pruritis as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Eye disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-4-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-4-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_4_EG000</p><p><b>title</b>: Diarrhea as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-4">EvidenceVariable Diarrhea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.09375</p><p><b>numberOfEvents</b>: 3</p><p><b>numberAffected</b>: 3</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-4-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-4-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_4_EG001</p><p><b>title</b>: Diarrhea as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-4">EvidenceVariable Diarrhea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.06666666666666667</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-4</b></p><a name="370505/NCT03640312-OtherAdverseEvent-4"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-4"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Diarrhea as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5).</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Diarrhea as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-5-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-5-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_5_EG000</p><p><b>title</b>: Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-5">EvidenceVariable Abdominal pain upper as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-5-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-5-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_5_EG001</p><p><b>title</b>: Abdominal pain upper as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-5">EvidenceVariable Abdominal pain upper as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.06666666666666667</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-5</b></p><a name="370505/NCT03640312-OtherAdverseEvent-5"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-5"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Abdominal pain upper as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Abdominal pain upper as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-6-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-6-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_6_EG000</p><p><b>title</b>: Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-6">EvidenceVariable Dry Mouth as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-6-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-6-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_6_EG001</p><p><b>title</b>: Dry Mouth as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-6">EvidenceVariable Dry Mouth as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-6</b></p><a name="370505/NCT03640312-OtherAdverseEvent-6"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-6"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Dry Mouth as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Dry Mouth as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-7-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-7-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_7_EG000</p><p><b>title</b>: Constipation as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-7">EvidenceVariable Constipation as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-7-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-7-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_7_EG001</p><p><b>title</b>: Constipation as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-7">EvidenceVariable Constipation as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-7</b></p><a name="370505/NCT03640312-OtherAdverseEvent-7"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-7"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Constipation as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Constipation as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-8-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-8-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_8_EG000</p><p><b>title</b>: Throat irritation as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-8">EvidenceVariable Throat irritation as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-8-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-8-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_8_EG001</p><p><b>title</b>: Throat irritation as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-8">EvidenceVariable Throat irritation as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-8</b></p><a name="370505/NCT03640312-OtherAdverseEvent-8"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-8"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Throat irritation as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, possible relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Throat irritation as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-9-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-9-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_9_EG000</p><p><b>title</b>: Nausea as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-9">EvidenceVariable Nausea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-9-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-9-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_9_EG001</p><p><b>title</b>: Nausea as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-9">EvidenceVariable Nausea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-9</b></p><a name="370505/NCT03640312-OtherAdverseEvent-9"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-9"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Nausea as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Nausea as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-10-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-10-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_10_EG000</p><p><b>title</b>: Dry throat as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-10">EvidenceVariable Dry throat as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-10-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-10-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_10_EG001</p><p><b>title</b>: Dry throat as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-10">EvidenceVariable Dry throat as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-10</b></p><a name="370505/NCT03640312-OtherAdverseEvent-10"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-10"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Dry throat as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, possible relatedness, temporarily withdrawn</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Dry throat as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-11-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-11-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_11_EG000</p><p><b>title</b>: Vomiting as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-11">EvidenceVariable Vomiting as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-11-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-11-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_11_EG001</p><p><b>title</b>: Vomiting as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-11">EvidenceVariable Vomiting as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-11</b></p><a name="370505/NCT03640312-OtherAdverseEvent-11"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-11"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Vomiting as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Vomiting as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Gastrointestinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-12-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-12-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_12_EG000</p><p><b>title</b>: Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-12">EvidenceVariable Feeling Hot as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-12-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-12-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_12_EG001</p><p><b>title</b>: Feeling Hot as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-12">EvidenceVariable Feeling Hot as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-12</b></p><a name="370505/NCT03640312-OtherAdverseEvent-12"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-12"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Feeling Hot as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Feeling Hot as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-13-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-13-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_13_EG000</p><p><b>title</b>: Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-13">EvidenceVariable Influenza like illness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-13-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-13-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_13_EG001</p><p><b>title</b>: Influenza like illness as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-13">EvidenceVariable Influenza like illness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-13</b></p><a name="370505/NCT03640312-OtherAdverseEvent-13"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-13"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Influenza like illness as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Influenza like illness as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-14-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-14-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_14_EG000</p><p><b>title</b>: Fatigue as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-14">EvidenceVariable Fatigue as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0625</p><p><b>numberOfEvents</b>: 3</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-14-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-14-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_14_EG001</p><p><b>title</b>: Fatigue as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-14">EvidenceVariable Fatigue as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-14</b></p><a name="370505/NCT03640312-OtherAdverseEvent-14"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-14"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Fatigue as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Fatigue as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-15-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-15-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_15_EG000</p><p><b>title</b>: Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-15">EvidenceVariable Peripheral swelling as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-15-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-15-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_15_EG001</p><p><b>title</b>: Peripheral swelling as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-15">EvidenceVariable Peripheral swelling as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.1</p><p><b>numberOfEvents</b>: 3</p><p><b>numberAffected</b>: 3</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-15</b></p><a name="370505/NCT03640312-OtherAdverseEvent-15"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-15"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Peripheral swelling as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Peripheral swelling as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-16-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-16-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_16_EG000</p><p><b>title</b>: Chest Pain as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-16">EvidenceVariable Chest Pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-16-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-16-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_16_EG001</p><p><b>title</b>: Chest Pain as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-16">EvidenceVariable Chest Pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-16</b></p><a name="370505/NCT03640312-OtherAdverseEvent-16"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-16"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Chest Pain as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Chest Pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-17-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-17-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_17_EG000</p><p><b>title</b>: Asthenia as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-17">EvidenceVariable Asthenia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-17-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-17-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_17_EG001</p><p><b>title</b>: Asthenia as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-17">EvidenceVariable Asthenia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-17</b></p><a name="370505/NCT03640312-OtherAdverseEvent-17"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-17"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Asthenia as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, resolved without sequelae, possible relatedness, temporarily withdrawn</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Asthenia as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-18-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-18-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_18_EG000</p><p><b>title</b>: Pain as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-18">EvidenceVariable Pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-18-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-18-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_18_EG001</p><p><b>title</b>: Pain as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-18">EvidenceVariable Pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-18</b></p><a name="370505/NCT03640312-OtherAdverseEvent-18"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-18"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Pain as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">General disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-19-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-19-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_19_EG000</p><p><b>title</b>: Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-19">EvidenceVariable Blood glucose increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-19-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-19-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_19_EG001</p><p><b>title</b>: Blood glucose increased as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-19">EvidenceVariable Blood glucose increased as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-19</b></p><a name="370505/NCT03640312-OtherAdverseEvent-19"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-19"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Blood glucose increased as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Blood glucose increased as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Investigations</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-20-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-20-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_20_EG000</p><p><b>title</b>: Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-20">EvidenceVariable Heart rate irregular as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0625</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-20-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-20-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_20_EG001</p><p><b>title</b>: Heart rate irregular as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-20">EvidenceVariable Heart rate irregular as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.06666666666666667</p><p><b>numberOfEvents</b>: 3</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-20</b></p><a name="370505/NCT03640312-OtherAdverseEvent-20"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-20"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Heart rate irregular as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Heart rate irregular as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Investigations</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-21-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-21-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_21_EG000</p><p><b>title</b>: Back pain as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-21">EvidenceVariable Back pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-21-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-21-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_21_EG001</p><p><b>title</b>: Back pain as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-21">EvidenceVariable Back pain as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-21</b></p><a name="370505/NCT03640312-OtherAdverseEvent-21"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-21"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Back pain as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>mild, ongoing at study exit, unlikely relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Back pain as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Musculoskeletal and connective tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-22-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-22-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_22_EG000</p><p><b>title</b>: Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-22">EvidenceVariable Muscle cramps/spasms as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-22-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-22-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_22_EG001</p><p><b>title</b>: Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-22">EvidenceVariable Muscle cramps/spasms as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-22</b></p><a name="370505/NCT03640312-OtherAdverseEvent-22"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-22"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Muscle cramps/spasms as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Muscle cramps/spasms as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Musculoskeletal and connective tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-23-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-23-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_23_EG000</p><p><b>title</b>: Headache as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-23">EvidenceVariable Headache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.15625</p><p><b>numberOfEvents</b>: 6</p><p><b>numberAffected</b>: 5</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-23-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-23-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_23_EG001</p><p><b>title</b>: Headache as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-23">EvidenceVariable Headache as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.06666666666666667</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-23</b></p><a name="370505/NCT03640312-OtherAdverseEvent-23"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-23"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Headache as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Headache as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Nervous system disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-24-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-24-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_24_EG000</p><p><b>title</b>: Dizziness as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-24">EvidenceVariable Dizziness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0625</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-24-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-24-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_24_EG001</p><p><b>title</b>: Dizziness as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-24">EvidenceVariable Dizziness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-24</b></p><a name="370505/NCT03640312-OtherAdverseEvent-24"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-24"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Dizziness as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Dizziness as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Nervous system disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-25-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-25-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_25_EG000</p><p><b>title</b>: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-25">EvidenceVariable Vision blurred as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-25-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-25-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_25_EG001</p><p><b>title</b>: Vision blurred as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-25">EvidenceVariable Vision blurred as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-25</b></p><a name="370505/NCT03640312-OtherAdverseEvent-25"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-25"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Vision blurred as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Vision blurred as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Nervous system disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-26-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-26-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_26_EG000</p><p><b>title</b>: Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-26">EvidenceVariable Hypoaesthesia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-26-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-26-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_26_EG001</p><p><b>title</b>: Hypoaesthesia as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-26">EvidenceVariable Hypoaesthesia as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-26</b></p><a name="370505/NCT03640312-OtherAdverseEvent-26"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-26"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Hypoaesthesia as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Hypoaesthesia as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Nervous system disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-27-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-27-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_27_EG000</p><p><b>title</b>: Anxiety as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-27">EvidenceVariable Anxiety as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.0625</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-27-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-27-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_27_EG001</p><p><b>title</b>: Anxiety as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-27">EvidenceVariable Anxiety as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-27</b></p><a name="370505/NCT03640312-OtherAdverseEvent-27"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-27"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Anxiety as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Anxiety as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Psychiatric disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-28-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-28-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_28_EG000</p><p><b>title</b>: Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-28">EvidenceVariable Nasopharyngitis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-28-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-28-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_28_EG001</p><p><b>title</b>: Nasopharyngitis as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-28">EvidenceVariable Nasopharyngitis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-28</b></p><a name="370505/NCT03640312-OtherAdverseEvent-28"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-28"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Nasopharyngitis as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Nasopharyngitis as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-29-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-29-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_29_EG000</p><p><b>title</b>: Cough as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-29">EvidenceVariable Cough as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-29-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-29-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_29_EG001</p><p><b>title</b>: Cough as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-29">EvidenceVariable Cough as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.1</p><p><b>numberOfEvents</b>: 3</p><p><b>numberAffected</b>: 3</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-29</b></p><a name="370505/NCT03640312-OtherAdverseEvent-29"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-29"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Cough as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Cough as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-30-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-30-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_30_EG000</p><p><b>title</b>: Dyspnea as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-30">EvidenceVariable Dyspnea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.09375</p><p><b>numberOfEvents</b>: 4</p><p><b>numberAffected</b>: 3</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-30-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-30-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_30_EG001</p><p><b>title</b>: Dyspnea as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-30">EvidenceVariable Dyspnea as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.06666666666666667</p><p><b>numberOfEvents</b>: 2</p><p><b>numberAffected</b>: 2</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-30</b></p><a name="370505/NCT03640312-OtherAdverseEvent-30"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-30"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Dyspnea as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Dyspnea as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-31-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-31-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_31_EG000</p><p><b>title</b>: Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-31">EvidenceVariable Respiration Abnormal as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-31-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-31-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_31_EG001</p><p><b>title</b>: Respiration Abnormal as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-31">EvidenceVariable Respiration Abnormal as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-31</b></p><a name="370505/NCT03640312-OtherAdverseEvent-31"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-31"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Respiration Abnormal as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Respiration Abnormal as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Respiratory, thoracic and mediastinal disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-32-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-32-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_32_EG000</p><p><b>title</b>: Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-32">EvidenceVariable Hyperhidrosis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-32-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-32-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_32_EG001</p><p><b>title</b>: Hyperhidrosis as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-32">EvidenceVariable Hyperhidrosis as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-32</b></p><a name="370505/NCT03640312-OtherAdverseEvent-32"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-32"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Hyperhidrosis as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Hyperhidrosis as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Skin and subcutaneous tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-33-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-33-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_33_EG000</p><p><b>title</b>: Rash as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-33">EvidenceVariable Rash as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03125</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-33-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-33-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_33_EG001</p><p><b>title</b>: Rash as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-33">EvidenceVariable Rash as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0</p><p><b>numberOfEvents</b>: 0</p><p><b>numberAffected</b>: 0</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-33</b></p><a name="370505/NCT03640312-OtherAdverseEvent-33"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-33"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Rash as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Rash as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Skin and subcutaneous tissue disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG000</b></p><a name="370505/NCT03640312-OtherAdverseEvent-34-EG000"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-34-EG000"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_34_EG000</p><p><b>title</b>: Dizziness as other adverse event for QUARTET LDQT in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-34">EvidenceVariable Dizziness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.125</p><p><b>numberOfEvents</b>: 4</p><p><b>numberAffected</b>: 4</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>32</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG001</b></p><a name="370505/NCT03640312-OtherAdverseEvent-34-EG001"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-34-EG001"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03640312_OtherAdverseEvent_34_EG001</p><p><b>title</b>: Dizziness as other adverse event for Candesartan in NCT03640312</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Candesartan</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Same as clinicaltrials.gov definition.</p>
<p>A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</p>
</div></blockquote><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="#hc370505/NCT03640312-OtherAdverseEvent-34">EvidenceVariable Dizziness as other adverse event</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:">Percentage</span></p><p><b>quantity</b>: 0.03333333333333333</p><p><b>numberOfEvents</b>: 1</p><p><b>numberAffected</b>: 1</p><h3>SampleSizes</h3><table class="grid"><tr><td style="display: none">-</td><td><b>KnownDataCount</b></td></tr><tr><td style="display: none">*</td><td>30</td></tr></table></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-34</b></p><a name="370505/NCT03640312-OtherAdverseEvent-34"> </a><a name="hc370505/NCT03640312-OtherAdverseEvent-34"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-variable-definition.html">VariableDefinition</a></p></div><p><b>title</b>: Dizziness as other adverse event</p><p><b>status</b>: Active</p><p><b>note</b>: </p><blockquote><div><p>5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)</p>
</div></blockquote><h3>Definitions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Concept</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Dizziness as other adverse event</span></td></tr></table><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Adverse event assessment type</span></p><p><b>value</b>: <span title="Codes:{http://hl7.org/fhir/definition-method systematic-assessment}">Systematic Assessment</span></p></blockquote><blockquote><p><b>definitionModifier</b></p><p><b>code</b>: <span title="Codes:">Source Vocabulary for Adverse Event Definition</span></p><p><b>value</b>: <span title="Codes:">MedDRA 23.0</span></p></blockquote><p><b>handling</b>: boolean variable</p><p><b>classifier</b>: <span title="Codes:">Other Adverse Event</span>, <span title="Codes:">Vascular disorders</span></p><h3>Timings</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>12 weeks</td></tr></table></blockquote></div>
  </text>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-AllCauseMortality"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="All-cause mortality (timeframe for NCT03640312)"/>
      <status value="active"/>
      <definition>
        <concept>
          <text value="All-cause mortality"/>
        </concept>
      </definition>
      <handling value="boolean"/>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-SeriousAdverseEvents"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Serious Adverse Events (timeframe for NCT03640312)"/>
      <status value="active"/>
      <definition>
        <concept>
          <text value="Serious Adverse Events"/>
        </concept>
      </definition>
      <handling value="boolean"/>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvents"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Other Adverse Events (timeframe for NCT03640312)"/>
      <status value="active"/>
      <definition>
        <concept>
          <text value="Other Adverse Events"/>
        </concept>
      </definition>
      <handling value="boolean"/>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-AllCauseMortality-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_AllCauseMortality_EG000"/>
      <title value="All-cause mortality for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
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        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-AllCauseMortality"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
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        <quantity>
          <value value="0"/>
        </quantity>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
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  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvents-EG000"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_SeriousAdverseEvents_EG000"/>
      <title value="Serious Adverse Events for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvents"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.0625"/>
        </quantity>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvents-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvents_EG000"/>
      <title value="Other Adverse Events for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvents"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.625"/>
        </quantity>
        <numberAffected value="20"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-AllCauseMortality-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_AllCauseMortality_EG001"/>
      <title value="All-cause mortality for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-AllCauseMortality"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvents-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_SeriousAdverseEvents_EG001"/>
      <title value="Serious Adverse Events for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvents"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvents-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvents_EG001"/>
      <title value="Other Adverse Events for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvents"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.4666666666666667"/>
        </quantity>
        <numberAffected value="14"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvent-0-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_SeriousAdverseEvent_0_EG000"/>
      <title
             value="Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvent-0"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvent-0-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_SeriousAdverseEvent_0_EG001"/>
      <title
             value="Road Traffic Accident as serious adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvent-0"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-SeriousAdverseEvent-0"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Road Traffic Accident as serious adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization."/>
      </note>
      <definition>
        <concept>
          <text value="Road Traffic Accident as serious adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Serious Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Injury, poisoning and procedural complications"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvent-1-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_SeriousAdverseEvent_1_EG000"/>
      <title
             value="Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvent-1"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-SeriousAdverseEvent-1-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_SeriousAdverseEvent_1_EG001"/>
      <title
             value="Chest Pain as serious adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-SeriousAdverseEvent-1"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-SeriousAdverseEvent-1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Chest Pain as serious adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization."/>
      </note>
      <definition>
        <concept>
          <text value="Chest Pain as serious adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Serious Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-0-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_0_EG000"/>
      <title
             value="Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-0"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-0-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_0_EG001"/>
      <title
             value="Vision blurred as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-0"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-0"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Vision blurred as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="2 Total events:

1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan
2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT"/>
      </note>
      <definition>
        <concept>
          <text value="Vision blurred as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Eye disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-1-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_1_EG000"/>
      <title
             value="Palpitations as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-1"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-1-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_1_EG001"/>
      <title
             value="Palpitations as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-1"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-1"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Palpitations as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken."/>
      </note>
      <definition>
        <concept>
          <text value="Palpitations as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Cardiac disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-2-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_2_EG000"/>
      <title
             value="Tinnitus as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-2"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-2-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_2_EG001"/>
      <title
             value="Tinnitus as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-2"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-2"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Tinnitus as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken."/>
      </note>
      <definition>
        <concept>
          <text value="Tinnitus as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Ear and labyrinth disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-3-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_3_EG000"/>
      <title
             value="Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-3"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-3-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_3_EG001"/>
      <title
             value="Eye pruritis as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-3"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-3"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Eye pruritis as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Eye pruritis as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Eye disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-4-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_4_EG000"/>
      <title
             value="Diarrhea as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-4"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.09375"/>
        </quantity>
        <numberOfEvents value="3"/>
        <numberAffected value="3"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-4-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_4_EG001"/>
      <title
             value="Diarrhea as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-4"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.06666666666666667"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-4"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Diarrhea as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5)."/>
      </note>
      <definition>
        <concept>
          <text value="Diarrhea as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-5-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_5_EG000"/>
      <title
             value="Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-5"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-5-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_5_EG001"/>
      <title
             value="Abdominal pain upper as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-5"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.06666666666666667"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-5"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Abdominal pain upper as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)"/>
      </note>
      <definition>
        <concept>
          <text value="Abdominal pain upper as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-6-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_6_EG000"/>
      <title
             value="Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-6"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-6-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_6_EG001"/>
      <title
             value="Dry Mouth as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-6"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-6"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Dry Mouth as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Dry Mouth as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-7-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_7_EG000"/>
      <title
             value="Constipation as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-7"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-7-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_7_EG001"/>
      <title
             value="Constipation as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-7"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-7"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Constipation as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Constipation as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-8-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_8_EG000"/>
      <title
             value="Throat irritation as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-8"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-8-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_8_EG001"/>
      <title
             value="Throat irritation as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-8"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-8"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Throat irritation as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, possible relatedness, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Throat irritation as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-9-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_9_EG000"/>
      <title
             value="Nausea as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-9"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-9-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_9_EG001"/>
      <title
             value="Nausea as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-9"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-9"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Nausea as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued"/>
      </note>
      <definition>
        <concept>
          <text value="Nausea as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-10-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_10_EG000"/>
      <title
             value="Dry throat as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-10"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-10-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_10_EG001"/>
      <title
             value="Dry throat as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-10"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-10"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Dry throat as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, possible relatedness, temporarily withdrawn"/>
      </note>
      <definition>
        <concept>
          <text value="Dry throat as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-11-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_11_EG000"/>
      <title
             value="Vomiting as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-11"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-11-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_11_EG001"/>
      <title
             value="Vomiting as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-11"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-11"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Vomiting as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn"/>
      </note>
      <definition>
        <concept>
          <text value="Vomiting as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Gastrointestinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-12-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_12_EG000"/>
      <title
             value="Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-12"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-12-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_12_EG001"/>
      <title
             value="Feeling Hot as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-12"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-12"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Feeling Hot as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued"/>
      </note>
      <definition>
        <concept>
          <text value="Feeling Hot as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-13-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_13_EG000"/>
      <title
             value="Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-13"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-13-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_13_EG001"/>
      <title
             value="Influenza like illness as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-13"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-13"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Influenza like illness as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Influenza like illness as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-14-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_14_EG000"/>
      <title
             value="Fatigue as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-14"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.0625"/>
        </quantity>
        <numberOfEvents value="3"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-14-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_14_EG001"/>
      <title
             value="Fatigue as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-14"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-14"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Fatigue as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)"/>
      </note>
      <definition>
        <concept>
          <text value="Fatigue as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-15-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_15_EG000"/>
      <title
             value="Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-15"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-15-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_15_EG001"/>
      <title
             value="Peripheral swelling as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-15"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.1"/>
        </quantity>
        <numberOfEvents value="3"/>
        <numberAffected value="3"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-15"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Peripheral swelling as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)"/>
      </note>
      <definition>
        <concept>
          <text value="Peripheral swelling as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-16-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_16_EG000"/>
      <title
             value="Chest Pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-16"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-16-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_16_EG001"/>
      <title
             value="Chest Pain as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-16"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-16"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Chest Pain as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Chest Pain as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-17-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_17_EG000"/>
      <title
             value="Asthenia as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-17"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-17-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_17_EG001"/>
      <title
             value="Asthenia as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-17"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-17"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Asthenia as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, resolved without sequelae, possible relatedness, temporarily withdrawn"/>
      </note>
      <definition>
        <concept>
          <text value="Asthenia as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-18-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_18_EG000"/>
      <title
             value="Pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-18"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-18-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_18_EG001"/>
      <title
             value="Pain as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-18"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-18"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Pain as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn"/>
      </note>
      <definition>
        <concept>
          <text value="Pain as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="General disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-19-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_19_EG000"/>
      <title
             value="Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-19"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-19-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_19_EG001"/>
      <title
             value="Blood glucose increased as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-19"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-19"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Blood glucose increased as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Blood glucose increased as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Investigations"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-20-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_20_EG000"/>
      <title
             value="Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-20"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.0625"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-20-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_20_EG001"/>
      <title
             value="Heart rate irregular as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-20"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.06666666666666667"/>
        </quantity>
        <numberOfEvents value="3"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-20"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Heart rate irregular as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)"/>
      </note>
      <definition>
        <concept>
          <text value="Heart rate irregular as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Investigations"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-21-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_21_EG000"/>
      <title
             value="Back pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-21"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-21-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_21_EG001"/>
      <title
             value="Back pain as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-21"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-21"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Back pain as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="mild, ongoing at study exit, unlikely relatedness, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Back pain as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Musculoskeletal and connective tissue disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-22-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_22_EG000"/>
      <title
             value="Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-22"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-22-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_22_EG001"/>
      <title
             value="Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-22"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-22"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Muscle cramps/spasms as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)"/>
      </note>
      <definition>
        <concept>
          <text value="Muscle cramps/spasms as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Musculoskeletal and connective tissue disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-23-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_23_EG000"/>
      <title
             value="Headache as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-23"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.15625"/>
        </quantity>
        <numberOfEvents value="6"/>
        <numberAffected value="5"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-23-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_23_EG001"/>
      <title
             value="Headache as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-23"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.06666666666666667"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-23"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Headache as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)"/>
      </note>
      <definition>
        <concept>
          <text value="Headache as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Nervous system disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-24-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_24_EG000"/>
      <title
             value="Dizziness as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-24"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.0625"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-24-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_24_EG001"/>
      <title
             value="Dizziness as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-24"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-24"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Dizziness as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)"/>
      </note>
      <definition>
        <concept>
          <text value="Dizziness as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Nervous system disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-25-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_25_EG000"/>
      <title
             value="Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-25"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-25-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_25_EG001"/>
      <title
             value="Vision blurred as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-25"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-25"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Vision blurred as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued"/>
      </note>
      <definition>
        <concept>
          <text value="Vision blurred as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Nervous system disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-26-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_26_EG000"/>
      <title
             value="Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-26"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03125"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-26-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_26_EG001"/>
      <title
             value="Hypoaesthesia as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-26"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-26"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Hypoaesthesia as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Hypoaesthesia as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Nervous system disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-27-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_27_EG000"/>
      <title
             value="Anxiety as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-27"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.0625"/>
        </quantity>
        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-27-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_27_EG001"/>
      <title
             value="Anxiety as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-27"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-27"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Anxiety as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)"/>
      </note>
      <definition>
        <concept>
          <text value="Anxiety as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Psychiatric disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-28-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_28_EG000"/>
      <title
             value="Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-28"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-28-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_28_EG001"/>
      <title
             value="Nasopharyngitis as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-28"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.03333333333333333"/>
        </quantity>
        <numberOfEvents value="1"/>
        <numberAffected value="1"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-28"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Nasopharyngitis as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken"/>
      </note>
      <definition>
        <concept>
          <text value="Nasopharyngitis as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Respiratory, thoracic and mediastinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-29-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_29_EG000"/>
      <title
             value="Cough as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-29"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0"/>
        </quantity>
        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-29-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_29_EG001"/>
      <title
             value="Cough as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-29"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.1"/>
        </quantity>
        <numberOfEvents value="3"/>
        <numberAffected value="3"/>
        <sampleSize>
          <knownDataCount value="30"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-29"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Cough as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3)"/>
      </note>
      <definition>
        <concept>
          <text value="Cough as other adverse event"/>
        </concept>
      </definition>
      <definitionModifier>
        <code>
          <text value="Adverse event assessment type"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/definition-method"/>
            <code value="systematic-assessment"/>
            <display value="Systematic Assessment"/>
          </coding>
        </valueCodeableConcept>
      </definitionModifier>
      <definitionModifier>
        <code>
          <text value="Source Vocabulary for Adverse Event Definition"/>
        </code>
        <valueCodeableConcept>
          <text value="MedDRA 23.0"/>
        </valueCodeableConcept>
      </definitionModifier>
      <handling value="boolean"/>
      <classifier>
        <text value="Other Adverse Event"/>
      </classifier>
      <classifier>
        <text value="Respiratory, thoracic and mediastinal disorders"/>
      </classifier>
      <timing>
        <text value="12 weeks"/>
      </timing>
    </EvidenceVariable>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-30-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_30_EG000"/>
      <title
             value="Dyspnea as other adverse event for QUARTET LDQT in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-30"/>
          <type value="EvidenceVariable"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <text value="Percentage"/>
        </statisticType>
        <quantity>
          <value value="0.09375"/>
        </quantity>
        <numberOfEvents value="4"/>
        <numberAffected value="3"/>
        <sampleSize>
          <knownDataCount value="32"/>
        </sampleSize>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-30-EG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_30_EG001"/>
      <title
             value="Dyspnea as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Candesartan"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
        </note>
        <variableRole value="outcome"/>
        <observed>
          <reference value="#NCT03640312-OtherAdverseEvent-30"/>
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        <quantity>
          <value value="0.06666666666666667"/>
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        <numberOfEvents value="2"/>
        <numberAffected value="2"/>
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          <knownDataCount value="30"/>
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      <id value="NCT03640312-OtherAdverseEvent-30"/>
      <meta>
        <profile
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      <title value="Dyspnea as other adverse event"/>
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      <note>
        <text
              value="6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)"/>
      </note>
      <definition>
        <concept>
          <text value="Dyspnea as other adverse event"/>
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      <classifier>
        <text value="Respiratory, thoracic and mediastinal disorders"/>
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      <id value="NCT03640312-OtherAdverseEvent-31-EG000"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_OtherAdverseEvent_31_EG000"/>
      <title
             value="Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312"/>
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          <display
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QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
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          <text
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A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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          <value value="0.03125"/>
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      <name value="NCT03640312_OtherAdverseEvent_31_EG001"/>
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             value="Respiration Abnormal as other adverse event for Candesartan in NCT03640312"/>
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          <display
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      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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        <variableRole value="outcome"/>
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          <reference value="#NCT03640312-OtherAdverseEvent-31"/>
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        <statisticType>
          <text value="Percentage"/>
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          <value value="0"/>
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        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
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          <knownDataCount value="30"/>
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      <id value="NCT03640312-OtherAdverseEvent-31"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
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      <title value="Respiration Abnormal as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken"/>
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        <concept>
          <text value="Respiration Abnormal as other adverse event"/>
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        <code>
          <text value="Adverse event assessment type"/>
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          <text value="Source Vocabulary for Adverse Event Definition"/>
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        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Respiratory, thoracic and mediastinal disorders"/>
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        <text value="12 weeks"/>
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      <id value="NCT03640312-OtherAdverseEvent-32-EG000"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
      </meta>
      <name value="NCT03640312_OtherAdverseEvent_32_EG000"/>
      <title
             value="Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312"/>
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      <variableDefinition>
        <description value="QUARTET LDQT"/>
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          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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          <value value="0.03125"/>
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          <knownDataCount value="32"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_OtherAdverseEvent_32_EG001"/>
      <title
             value="Hyperhidrosis as other adverse event for Candesartan in NCT03640312"/>
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        <description value="Candesartan"/>
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          <display
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Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
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      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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          <value value="0.03333333333333333"/>
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          <knownDataCount value="30"/>
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        <profile
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      <title value="Hyperhidrosis as other adverse event"/>
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        <text
              value="2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)"/>
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          <text value="Source Vocabulary for Adverse Event Definition"/>
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      <classifier>
        <text value="Skin and subcutaneous tissue disorders"/>
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        <text value="12 weeks"/>
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  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-33-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_OtherAdverseEvent_33_EG000"/>
      <title
             value="Rash as other adverse event for QUARTET LDQT in NCT03640312"/>
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      <variableDefinition>
        <description value="QUARTET LDQT"/>
        <variableRole value="population"/>
        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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        <variableRole value="outcome"/>
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          <reference value="#NCT03640312-OtherAdverseEvent-33"/>
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        <numberOfEvents value="1"/>
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          <knownDataCount value="32"/>
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        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_OtherAdverseEvent_33_EG001"/>
      <title
             value="Rash as other adverse event for Candesartan in NCT03640312"/>
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        <description value="Candesartan"/>
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        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
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      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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        <variableRole value="outcome"/>
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          <reference value="#NCT03640312-OtherAdverseEvent-33"/>
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        <statisticType>
          <text value="Percentage"/>
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          <value value="0"/>
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        <numberOfEvents value="0"/>
        <numberAffected value="0"/>
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          <knownDataCount value="30"/>
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  <contained>
    <EvidenceVariable>
      <id value="NCT03640312-OtherAdverseEvent-33"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
      </meta>
      <title value="Rash as other adverse event"/>
      <status value="active"/>
      <note>
        <text
              value="Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken"/>
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      <definition>
        <concept>
          <text value="Rash as other adverse event"/>
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          <text value="Adverse event assessment type"/>
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      <handling value="boolean"/>
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        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Skin and subcutaneous tissue disorders"/>
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      <timing>
        <text value="12 weeks"/>
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  <contained>
    <Evidence>
      <id value="NCT03640312-OtherAdverseEvent-34-EG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
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      <name value="NCT03640312_OtherAdverseEvent_34_EG000"/>
      <title
             value="Dizziness as other adverse event for QUARTET LDQT in NCT03640312"/>
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      <variableDefinition>
        <description value="QUARTET LDQT"/>
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        <observed>
          <display
                   value="Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
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      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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          <reference value="#NCT03640312-OtherAdverseEvent-34"/>
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        <numberOfEvents value="4"/>
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        <profile
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      <name value="NCT03640312_OtherAdverseEvent_34_EG001"/>
      <title
             value="Dizziness as other adverse event for Candesartan in NCT03640312"/>
      <status value="active"/>
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        <description value="Candesartan"/>
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        <observed>
          <display
                   value="Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
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      <variableDefinition>
        <note>
          <text
                value="Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database."/>
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          <value value="0.03333333333333333"/>
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        <numberOfEvents value="1"/>
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          <knownDataCount value="30"/>
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      <id value="NCT03640312-OtherAdverseEvent-34"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"/>
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      <title value="Dizziness as other adverse event"/>
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      <note>
        <text
              value="5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)"/>
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      <definitionModifier>
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          <text value="MedDRA 23.0"/>
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      <handling value="boolean"/>
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        <text value="Other Adverse Event"/>
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      <classifier>
        <text value="Vascular disorders"/>
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        <text value="12 weeks"/>
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  <date value="2025-08-18T13:22:42.074Z"/>
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  <title value="Adverse Events Report for NCT03640312"/>
  <custodian>🔗 
    <reference value="Organization/118079"/>
    <type value="Organization"/>
    <display value="Computable Publishing LLC"/>
  </custodian>
  <relatesTo>
    <type value="cite-as"/>
    <targetMarkdown
                    value="Adverse Events Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370505. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370505. Computable resource at: https://fevir.net/FLI/DocumentForComposition370505."/>
  </relatesTo>
  <section>
    <title value="Events Frequency Threshold"/>
    <code>
      <text value="EventsFrequencyThreshold"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">0%</div>
    </text>
  </section>
  <section>
    <title value="Events Time Frame"/>
    <code>
      <text value="EventsTimeFrame"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">12 weeks</div>
    </text>
  </section>
  <section>
    <title value="Events Description"/>
    <code>
      <text value="EventsDescription"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.</div>
    </text>
  </section>
  <section>
    <title value="QUARTET LDQT"/>
    <code>
      <text value="EG000 QUARTET LDQT"/>
    </code>
    <section>
      <title value="Event Group Description"/>
      <code>
        <text value="EventGroupDescription"/>
      </code>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>
      </text>
    </section>
  </section>
  <section>
    <title value="Candesartan"/>
    <code>
      <text value="EG001 Candesartan"/>
    </code>
    <section>
      <title value="Event Group Description"/>
      <code>
        <text value="EventGroupDescription"/>
      </code>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">Patients randomized to the comparison arm will take a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>
      </text>
    </section>
  </section>
  <section>
    <title value="Total Mortality"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Mortality"/>
    </code>
    <focus>
      <reference value="#NCT03640312-AllCauseMortality"/>
      <type value="EvidenceVariable"/>
      <display value="All-cause mortality (timeframe for NCT03640312)"/>
    </focus>
    <entry>
      <reference value="#NCT03640312-AllCauseMortality-EG000"/>
      <type value="Evidence"/>
      <display value="All-cause mortality for QUARTET LDQT in NCT03640312"/>
    </entry>
    <entry>
      <reference value="#NCT03640312-AllCauseMortality-EG001"/>
      <type value="Evidence"/>
      <display value="All-cause mortality for Candesartan in NCT03640312"/>
    </entry>
  </section>
  <section>
    <title value="Total Serious Events"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Serious Events"/>
    </code>
    <focus>
      <reference value="#NCT03640312-SeriousAdverseEvents"/>
      <type value="EvidenceVariable"/>
      <display value="Serious Adverse Events (timeframe for NCT03640312)"/>
    </focus>
    <entry>
      <reference value="#NCT03640312-SeriousAdverseEvents-EG000"/>
      <type value="Evidence"/>
      <display
               value="Serious Adverse Events for QUARTET LDQT in NCT03640312"/>
    </entry>
    <entry>
      <reference value="#NCT03640312-SeriousAdverseEvents-EG001"/>
      <type value="Evidence"/>
      <display value="Serious Adverse Events for Candesartan in NCT03640312"/>
    </entry>
  </section>
  <section>
    <title value="Total Other Events"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Total Other Events"/>
    </code>
    <focus>
      <reference value="#NCT03640312-OtherAdverseEvents"/>
      <type value="EvidenceVariable"/>
      <display value="Other Adverse Events (timeframe for NCT03640312)"/>
    </focus>
    <entry>
      <reference value="#NCT03640312-OtherAdverseEvents-EG000"/>
      <type value="Evidence"/>
      <display value="Other Adverse Events for QUARTET LDQT in NCT03640312"/>
    </entry>
    <entry>
      <reference value="#NCT03640312-OtherAdverseEvents-EG001"/>
      <type value="Evidence"/>
      <display value="Other Adverse Events for Candesartan in NCT03640312"/>
    </entry>
  </section>
  <section>
    <title value="Serious Event List"/>
    <code>
      <text value="SeriousEventList"/>
    </code>
    <section>
      <title value="Road Traffic Accident"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-SeriousAdverseEvent-0"/>
        <type value="EvidenceVariable"/>
        <display value="Road Traffic Accident as serious adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-SeriousAdverseEvent-0-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-SeriousAdverseEvent-0-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Road Traffic Accident as serious adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Chest Pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-SeriousAdverseEvent-1"/>
        <type value="EvidenceVariable"/>
        <display value="Chest Pain as serious adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-SeriousAdverseEvent-1-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-SeriousAdverseEvent-1-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Chest Pain as serious adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
  </section>
  <section>
    <title value="Other Event List"/>
    <code>
      <text value="OtherEventList"/>
    </code>
    <section>
      <title value="Vision blurred"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-0"/>
        <type value="EvidenceVariable"/>
        <display value="Vision blurred as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-0-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-0-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Vision blurred as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Palpitations"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-1"/>
        <type value="EvidenceVariable"/>
        <display value="Palpitations as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-1-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Palpitations as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-1-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Palpitations as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Tinnitus"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-2"/>
        <type value="EvidenceVariable"/>
        <display value="Tinnitus as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-2-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Tinnitus as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-2-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Tinnitus as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Eye pruritis"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-3"/>
        <type value="EvidenceVariable"/>
        <display value="Eye pruritis as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-3-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-3-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Eye pruritis as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Diarrhea"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-4"/>
        <type value="EvidenceVariable"/>
        <display value="Diarrhea as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-4-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Diarrhea as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-4-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Diarrhea as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Abdominal pain upper"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-5"/>
        <type value="EvidenceVariable"/>
        <display value="Abdominal pain upper as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-5-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-5-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Abdominal pain upper as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Dry Mouth"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-6"/>
        <type value="EvidenceVariable"/>
        <display value="Dry Mouth as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-6-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-6-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Dry Mouth as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Constipation"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-7"/>
        <type value="EvidenceVariable"/>
        <display value="Constipation as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-7-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Constipation as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-7-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Constipation as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Throat irritation"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-8"/>
        <type value="EvidenceVariable"/>
        <display value="Throat irritation as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-8-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Throat irritation as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-8-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Throat irritation as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Nausea"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-9"/>
        <type value="EvidenceVariable"/>
        <display value="Nausea as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-9-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Nausea as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-9-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Nausea as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Dry throat"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-10"/>
        <type value="EvidenceVariable"/>
        <display value="Dry throat as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-10-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Dry throat as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-10-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Dry throat as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Vomiting"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-11"/>
        <type value="EvidenceVariable"/>
        <display value="Vomiting as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-11-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Vomiting as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-11-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Vomiting as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Feeling Hot"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-12"/>
        <type value="EvidenceVariable"/>
        <display value="Feeling Hot as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-12-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-12-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Feeling Hot as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Influenza like illness"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-13"/>
        <type value="EvidenceVariable"/>
        <display value="Influenza like illness as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-13-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-13-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Influenza like illness as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Fatigue"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-14"/>
        <type value="EvidenceVariable"/>
        <display value="Fatigue as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-14-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Fatigue as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-14-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Fatigue as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Peripheral swelling"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-15"/>
        <type value="EvidenceVariable"/>
        <display value="Peripheral swelling as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-15-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-15-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Peripheral swelling as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Chest Pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-16"/>
        <type value="EvidenceVariable"/>
        <display value="Chest Pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-16-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Chest Pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-16-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Chest Pain as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Asthenia"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-17"/>
        <type value="EvidenceVariable"/>
        <display value="Asthenia as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-17-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Asthenia as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-17-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Asthenia as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-18"/>
        <type value="EvidenceVariable"/>
        <display value="Pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-18-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-18-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Pain as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Blood glucose increased"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-19"/>
        <type value="EvidenceVariable"/>
        <display value="Blood glucose increased as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-19-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-19-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Blood glucose increased as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Heart rate irregular"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-20"/>
        <type value="EvidenceVariable"/>
        <display value="Heart rate irregular as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-20-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-20-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Heart rate irregular as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Back pain"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-21"/>
        <type value="EvidenceVariable"/>
        <display value="Back pain as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-21-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Back pain as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-21-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Back pain as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Muscle cramps/spasms"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-22"/>
        <type value="EvidenceVariable"/>
        <display value="Muscle cramps/spasms as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-22-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-22-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Headache"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-23"/>
        <type value="EvidenceVariable"/>
        <display value="Headache as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-23-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Headache as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-23-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Headache as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Dizziness"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-24"/>
        <type value="EvidenceVariable"/>
        <display value="Dizziness as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-24-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Dizziness as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-24-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Dizziness as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Vision blurred"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-25"/>
        <type value="EvidenceVariable"/>
        <display value="Vision blurred as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-25-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-25-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Vision blurred as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Hypoaesthesia"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-26"/>
        <type value="EvidenceVariable"/>
        <display value="Hypoaesthesia as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-26-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-26-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Hypoaesthesia as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Anxiety"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-27"/>
        <type value="EvidenceVariable"/>
        <display value="Anxiety as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-27-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Anxiety as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-27-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Anxiety as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Nasopharyngitis"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-28"/>
        <type value="EvidenceVariable"/>
        <display value="Nasopharyngitis as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-28-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-28-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Nasopharyngitis as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Cough"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-29"/>
        <type value="EvidenceVariable"/>
        <display value="Cough as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-29-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Cough as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-29-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Cough as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Dyspnea"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-30"/>
        <type value="EvidenceVariable"/>
        <display value="Dyspnea as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-30-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Dyspnea as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-30-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Dyspnea as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Respiration Abnormal"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-31"/>
        <type value="EvidenceVariable"/>
        <display value="Respiration Abnormal as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-31-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-31-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Respiration Abnormal as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Hyperhidrosis"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-32"/>
        <type value="EvidenceVariable"/>
        <display value="Hyperhidrosis as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-32-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-32-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Hyperhidrosis as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Rash"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-33"/>
        <type value="EvidenceVariable"/>
        <display value="Rash as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-33-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Rash as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-33-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Rash as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
    <section>
      <title value="Dizziness"/>
      <code>
        <coding>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="results"/>
          <display value="Results"/>
        </coding>
      </code>
      <focus>
        <reference value="#NCT03640312-OtherAdverseEvent-34"/>
        <type value="EvidenceVariable"/>
        <display value="Dizziness as other adverse event"/>
      </focus>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-34-EG000"/>
        <type value="Evidence"/>
        <display
                 value="Dizziness as other adverse event for QUARTET LDQT in NCT03640312"/>
      </entry>
      <entry>
        <reference value="#NCT03640312-OtherAdverseEvent-34-EG001"/>
        <type value="Evidence"/>
        <display
                 value="Dizziness as other adverse event for Candesartan in NCT03640312"/>
      </entry>
    </section>
  </section>
</Composition>