Adverse Events Report for NCT03640312 - JSON 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 - JSON Representation

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{
  "resourceType" : "Composition",
  "id" : "370505",
  "meta" : {
    "versionId" : "25",
    "lastUpdated" : "2025-08-18T13:22:42.074Z",
    "profile" : [
      🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report"
    ]
  },
  "text" : {
    "status" : "extensions",
    "div" : "<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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n<ol>\n<li>Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan</li>\n<li>Severe, resolved without sequelae, unlikely related, no action taken, LDQT</li>\n</ol>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>\n</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.\n\nQUARTET 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>\n<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>\n</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>\n</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: 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>\n<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>\n</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>\n</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>"
  },
  "contained" : [
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-AllCauseMortality",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "All-cause mortality (timeframe for NCT03640312)",
      "status" : "active",
      "definition" : {
        "concept" : {
          "text" : "All-cause mortality"
        }
      },
      "handling" : "boolean",
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-SeriousAdverseEvents",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Serious Adverse Events (timeframe for NCT03640312)",
      "status" : "active",
      "definition" : {
        "concept" : {
          "text" : "Serious Adverse Events"
        }
      },
      "handling" : "boolean",
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvents",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Other Adverse Events (timeframe for NCT03640312)",
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      "definition" : {
        "concept" : {
          "text" : "Other Adverse Events"
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      },
      "handling" : "boolean",
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        "text" : "12 weeks"
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      "resourceType" : "Evidence",
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      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_AllCauseMortality_EG000",
      "title" : "All-cause mortality for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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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          "statisticType" : {
            "text" : "Percentage"
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          },
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          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-SeriousAdverseEvents-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvents_EG000",
      "title" : "Serious Adverse Events for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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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          "observed" : {
            "reference" : "#NCT03640312-SeriousAdverseEvents",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.0625
          },
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvents-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvents_EG000",
      "title" : "Other Adverse Events for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvents",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.625
          },
          "numberAffected" : 20,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
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      "resourceType" : "Evidence",
      "id" : "NCT03640312-AllCauseMortality-EG001",
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        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_AllCauseMortality_EG001",
      "title" : "All-cause mortality for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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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      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
            "value" : 0
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          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-SeriousAdverseEvents-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvents_EG001",
      "title" : "Serious Adverse Events for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
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        },
        {
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            {
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      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
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          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvents-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvents_EG001",
      "title" : "Other Adverse Events for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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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      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
            "value" : 0.4666666666666667
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          "numberAffected" : 14,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
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      "id" : "NCT03640312-SeriousAdverseEvent-0-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvent_0_EG000",
      "title" : "Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
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          "variableRole" : "population",
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-0",
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        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-SeriousAdverseEvent-0-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvent_0_EG001",
      "title" : "Road Traffic Accident as serious adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-0",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-SeriousAdverseEvent-0",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Road Traffic Accident as serious adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization."
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Road Traffic Accident as serious adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Serious Adverse Event"
        },
        {
          "text" : "Injury, poisoning and procedural complications"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-SeriousAdverseEvent-1-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvent_1_EG000",
      "title" : "Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-1",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-SeriousAdverseEvent-1-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_SeriousAdverseEvent_1_EG001",
      "title" : "Chest Pain as serious adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-1",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-SeriousAdverseEvent-1",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Chest Pain as serious adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization."
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Chest Pain as serious adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Serious Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-0-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_0_EG000",
      "title" : "Vision blurred as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-0",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-0-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_0_EG001",
      "title" : "Vision blurred as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-0",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-0",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Vision blurred as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "2 Total events:\n\n1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan\n2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Vision blurred as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Eye disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-1-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_1_EG000",
      "title" : "Palpitations as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-1",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-1-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_1_EG001",
      "title" : "Palpitations as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-1",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-1",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Palpitations as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken."
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Palpitations as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Cardiac disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-2-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_2_EG000",
      "title" : "Tinnitus as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-2",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-2-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_2_EG001",
      "title" : "Tinnitus as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-2",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-2",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Tinnitus as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken."
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Tinnitus as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Ear and labyrinth disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-3-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_3_EG000",
      "title" : "Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-3",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-3-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_3_EG001",
      "title" : "Eye pruritis as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-3",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-3",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Eye pruritis as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Eye pruritis as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Eye disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-4-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_4_EG000",
      "title" : "Diarrhea as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-4",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.09375
          },
          "numberOfEvents" : 3,
          "numberAffected" : 3,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-4-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_4_EG001",
      "title" : "Diarrhea as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-4",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.06666666666666667
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-4",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Diarrhea as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)."
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Diarrhea as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-5-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_5_EG000",
      "title" : "Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-5",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-5-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_5_EG001",
      "title" : "Abdominal pain upper as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-5",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.06666666666666667
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-5",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Abdominal pain upper as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Abdominal pain upper as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-6-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_6_EG000",
      "title" : "Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-6",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-6-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_6_EG001",
      "title" : "Dry Mouth as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-6",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-6",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Dry Mouth as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Dry Mouth as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-7-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_7_EG000",
      "title" : "Constipation as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-7",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-7-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_7_EG001",
      "title" : "Constipation as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-7",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-7",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Constipation as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Constipation as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-8-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_8_EG000",
      "title" : "Throat irritation as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-8",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-8-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_8_EG001",
      "title" : "Throat irritation as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-8",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-8",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Throat irritation as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, possible relatedness, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Throat irritation as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-9-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_9_EG000",
      "title" : "Nausea as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-9",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-9-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_9_EG001",
      "title" : "Nausea as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-9",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-9",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Nausea as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Nausea as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-10-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_10_EG000",
      "title" : "Dry throat as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-10",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-10-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_10_EG001",
      "title" : "Dry throat as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-10",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-10",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Dry throat as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, possible relatedness, temporarily withdrawn"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Dry throat as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-11-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_11_EG000",
      "title" : "Vomiting as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-11",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-11-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_11_EG001",
      "title" : "Vomiting as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-11",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-11",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Vomiting as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Vomiting as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Gastrointestinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-12-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_12_EG000",
      "title" : "Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-12",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-12-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_12_EG001",
      "title" : "Feeling Hot as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
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            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-12",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-12",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Feeling Hot as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Feeling Hot as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
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                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-13-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_13_EG000",
      "title" : "Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-13",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-13-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_13_EG001",
      "title" : "Influenza like illness as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-13",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-13",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Influenza like illness as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Influenza like illness as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-14-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_14_EG000",
      "title" : "Fatigue as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-14",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.0625
          },
          "numberOfEvents" : 3,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-14-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_14_EG001",
      "title" : "Fatigue as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-14",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-14",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Fatigue as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Fatigue as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-15-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_15_EG000",
      "title" : "Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-15",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-15-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_15_EG001",
      "title" : "Peripheral swelling as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-15",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.1
          },
          "numberOfEvents" : 3,
          "numberAffected" : 3,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-15",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Peripheral swelling as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Peripheral swelling as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-16-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_16_EG000",
      "title" : "Chest Pain as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-16",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-16-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_16_EG001",
      "title" : "Chest Pain as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-16",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-16",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Chest Pain as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Chest Pain as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-17-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_17_EG000",
      "title" : "Asthenia as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-17",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-17-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_17_EG001",
      "title" : "Asthenia as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-17",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-17",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Asthenia as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, resolved without sequelae, possible relatedness, temporarily withdrawn"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Asthenia as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-18-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_18_EG000",
      "title" : "Pain as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-18",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-18-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_18_EG001",
      "title" : "Pain as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-18",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-18",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Pain as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Pain as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "General disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-19-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_19_EG000",
      "title" : "Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-19",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-19-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_19_EG001",
      "title" : "Blood glucose increased as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-19",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-19",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Blood glucose increased as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Blood glucose increased as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Investigations"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-20-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_20_EG000",
      "title" : "Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-20",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.0625
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-20-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_20_EG001",
      "title" : "Heart rate irregular as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-20",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.06666666666666667
          },
          "numberOfEvents" : 3,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-20",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Heart rate irregular as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Heart rate irregular as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Investigations"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-21-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_21_EG000",
      "title" : "Back pain as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-21",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-21-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_21_EG001",
      "title" : "Back pain as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-21",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-21",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Back pain as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "mild, ongoing at study exit, unlikely relatedness, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Back pain as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Musculoskeletal and connective tissue disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-22-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_22_EG000",
      "title" : "Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-22",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-22-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_22_EG001",
      "title" : "Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-22",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-22",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Muscle cramps/spasms as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Muscle cramps/spasms as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Musculoskeletal and connective tissue disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-23-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_23_EG000",
      "title" : "Headache as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-23",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.15625
          },
          "numberOfEvents" : 6,
          "numberAffected" : 5,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-23-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_23_EG001",
      "title" : "Headache as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-23",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.06666666666666667
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-23",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Headache as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Headache as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Nervous system disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-24-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_24_EG000",
      "title" : "Dizziness as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-24",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.0625
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-24-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_24_EG001",
      "title" : "Dizziness as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-24",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-24",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Dizziness as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Dizziness as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Nervous system disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-25-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_25_EG000",
      "title" : "Vision blurred as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-25",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-25-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_25_EG001",
      "title" : "Vision blurred as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-25",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-25",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Vision blurred as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Vision blurred as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
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            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Nervous system disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-26-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_26_EG000",
      "title" : "Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-26",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-26-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_26_EG001",
      "title" : "Hypoaesthesia as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-26",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-26",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Hypoaesthesia as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Hypoaesthesia as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
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            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Nervous system disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-27-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_27_EG000",
      "title" : "Anxiety as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-27",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.0625
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-27-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_27_EG001",
      "title" : "Anxiety as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-27",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-27",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Anxiety as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Anxiety as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Psychiatric disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-28-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_28_EG000",
      "title" : "Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-28",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-28-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_28_EG001",
      "title" : "Nasopharyngitis as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-28",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03333333333333333
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-28",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Nasopharyngitis as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Nasopharyngitis as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Respiratory, thoracic and mediastinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-29-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_29_EG000",
      "title" : "Cough as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-29",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-29-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_29_EG001",
      "title" : "Cough as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-29",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.1
          },
          "numberOfEvents" : 3,
          "numberAffected" : 3,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-29",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Cough as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Cough as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Respiratory, thoracic and mediastinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-30-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_30_EG000",
      "title" : "Dyspnea as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-30",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.09375
          },
          "numberOfEvents" : 4,
          "numberAffected" : 3,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-30-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_30_EG001",
      "title" : "Dyspnea as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-30",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.06666666666666667
          },
          "numberOfEvents" : 2,
          "numberAffected" : 2,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-30",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Dyspnea as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
        "concept" : {
          "text" : "Dyspnea as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
          },
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://hl7.org/fhir/definition-method",
                "code" : "systematic-assessment",
                "display" : "Systematic Assessment"
              }
            ]
          }
        },
        {
          "code" : {
            "text" : "Source Vocabulary for Adverse Event Definition"
          },
          "valueCodeableConcept" : {
            "text" : "MedDRA 23.0"
          }
        }
      ],
      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Respiratory, thoracic and mediastinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-31-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_31_EG000",
      "title" : "Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
          "variableRole" : "population",
          "observed" : {
            "display" : "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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-31",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0.03125
          },
          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-31-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_31_EG001",
      "title" : "Respiration Abnormal as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "Candesartan",
          "variableRole" : "population",
          "observed" : {
            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-31",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-31",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Respiration Abnormal as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken"
        }
      ],
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        "concept" : {
          "text" : "Respiration Abnormal as other adverse event"
        }
      },
      "definitionModifier" : [
        {
          "code" : {
            "text" : "Adverse event assessment type"
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      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
        },
        {
          "text" : "Respiratory, thoracic and mediastinal disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-32-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_32_EG000",
      "title" : "Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
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        {
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        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-32",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
            "value" : 0.03125
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          "numberOfEvents" : 1,
          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-32-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_32_EG001",
      "title" : "Hyperhidrosis as other adverse event for Candesartan in NCT03640312",
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        {
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        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
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      ],
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          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
            "value" : 0.03333333333333333
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          "numberAffected" : 1,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-32",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Hyperhidrosis as other adverse event",
      "status" : "active",
      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
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          "text" : "Hyperhidrosis as other adverse event"
        }
      },
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      "handling" : "boolean",
      "classifier" : [
        {
          "text" : "Other Adverse Event"
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        {
          "text" : "Skin and subcutaneous tissue disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-33-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_33_EG000",
      "title" : "Rash as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
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        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
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            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
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        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
      "name" : "NCT03640312_OtherAdverseEvent_33_EG001",
      "title" : "Rash as other adverse event for Candesartan in NCT03640312",
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        {
          "description" : "Candesartan",
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          }
        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
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            "reference" : "#NCT03640312-OtherAdverseEvent-33",
            "type" : "EvidenceVariable"
          }
        }
      ],
      "statistic" : [
        {
          "statisticType" : {
            "text" : "Percentage"
          },
          "quantity" : {
            "value" : 0
          },
          "numberOfEvents" : 0,
          "numberAffected" : 0,
          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-33",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
        ]
      },
      "title" : "Rash as other adverse event",
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        {
          "text" : "Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken"
        }
      ],
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          "text" : "Rash as other adverse event"
        }
      },
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      "handling" : "boolean",
      "classifier" : [
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          "text" : "Other Adverse Event"
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        {
          "text" : "Skin and subcutaneous tissue disorders"
        }
      ],
      "timing" : {
        "text" : "12 weeks"
      }
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-34-EG000",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_34_EG000",
      "title" : "Dizziness as other adverse event for QUARTET LDQT in NCT03640312",
      "status" : "active",
      "variableDefinition" : [
        {
          "description" : "QUARTET LDQT",
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        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
          "observed" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-34",
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          }
        }
      ],
      "statistic" : [
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          "statisticType" : {
            "text" : "Percentage"
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          "quantity" : {
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          "numberAffected" : 4,
          "sampleSize" : {
            "knownDataCount" : 32
          }
        }
      ]
    },
    {
      "resourceType" : "Evidence",
      "id" : "NCT03640312-OtherAdverseEvent-34-EG001",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name" : "NCT03640312_OtherAdverseEvent_34_EG001",
      "title" : "Dizziness as other adverse event for Candesartan in NCT03640312",
      "status" : "active",
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        {
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            "display" : "Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."
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        },
        {
          "note" : [
            {
              "text" : "Same as clinicaltrials.gov definition.\n\nA 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."
            }
          ],
          "variableRole" : "outcome",
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        }
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          "statisticType" : {
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          "quantity" : {
            "value" : 0.03333333333333333
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          "sampleSize" : {
            "knownDataCount" : 30
          }
        }
      ]
    },
    {
      "resourceType" : "EvidenceVariable",
      "id" : "NCT03640312-OtherAdverseEvent-34",
      "meta" : {
        "profile" : [
          🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
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      },
      "title" : "Dizziness as other adverse event",
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      "note" : [
        {
          "text" : "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)"
        }
      ],
      "definition" : {
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          "text" : "Dizziness as other adverse event"
        }
      },
      "definitionModifier" : [
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      ],
      "handling" : "boolean",
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        {
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        {
          "text" : "Vascular disorders"
        }
      ],
      "timing" : {
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      }
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      "value" : "NCT03640312-adverse-events-report",
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  "date" : "2025-08-18T13:22:42.074Z",
  "author" : [
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      "display" : "[No author listed.]"
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  "title" : "Adverse Events Report for NCT03640312",
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    }
  ],
  "section" : [
    {
      "title" : "Events Frequency Threshold",
      "code" : {
        "text" : "EventsFrequencyThreshold"
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">0%</div>"
      }
    },
    {
      "title" : "Events Time Frame",
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      "text" : {
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        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">12 weeks</div>"
      }
    },
    {
      "title" : "Events Description",
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        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Same as clinicaltrials.gov definition.\n\nA 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>"
      }
    },
    {
      "title" : "QUARTET LDQT",
      "code" : {
        "text" : "EG000 QUARTET LDQT"
      },
      "section" : [
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          "title" : "Event Group Description",
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            "status" : "generated",
            "div" : "<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.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</div>"
          }
        }
      ]
    },
    {
      "title" : "Candesartan",
      "code" : {
        "text" : "EG001 Candesartan"
      },
      "section" : [
        {
          "title" : "Event Group Description",
          "code" : {
            "text" : "EventGroupDescription"
          },
          "text" : {
            "status" : "generated",
            "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Patients randomized to the comparison arm will take a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</div>"
          }
        }
      ]
    },
    {
      "title" : "Total Mortality",
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            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "results",
            "display" : "Results"
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        ],
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      },
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        "display" : "All-cause mortality (timeframe for NCT03640312)"
      },
      "entry" : [
        {
          "reference" : "#NCT03640312-AllCauseMortality-EG000",
          "type" : "Evidence",
          "display" : "All-cause mortality for QUARTET LDQT in NCT03640312"
        },
        {
          "reference" : "#NCT03640312-AllCauseMortality-EG001",
          "type" : "Evidence",
          "display" : "All-cause mortality for Candesartan in NCT03640312"
        }
      ]
    },
    {
      "title" : "Total Serious Events",
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        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "results",
            "display" : "Results"
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        ],
        "text" : "Total Serious Events"
      },
      "focus" : {
        "reference" : "#NCT03640312-SeriousAdverseEvents",
        "type" : "EvidenceVariable",
        "display" : "Serious Adverse Events (timeframe for NCT03640312)"
      },
      "entry" : [
        {
          "reference" : "#NCT03640312-SeriousAdverseEvents-EG000",
          "type" : "Evidence",
          "display" : "Serious Adverse Events for QUARTET LDQT in NCT03640312"
        },
        {
          "reference" : "#NCT03640312-SeriousAdverseEvents-EG001",
          "type" : "Evidence",
          "display" : "Serious Adverse Events for Candesartan in NCT03640312"
        }
      ]
    },
    {
      "title" : "Total Other Events",
      "code" : {
        "coding" : [
          {
            "system" : "https://fevir.net/resources/CodeSystem/179423",
            "code" : "results",
            "display" : "Results"
          }
        ],
        "text" : "Total Other Events"
      },
      "focus" : {
        "reference" : "#NCT03640312-OtherAdverseEvents",
        "type" : "EvidenceVariable",
        "display" : "Other Adverse Events (timeframe for NCT03640312)"
      },
      "entry" : [
        {
          "reference" : "#NCT03640312-OtherAdverseEvents-EG000",
          "type" : "Evidence",
          "display" : "Other Adverse Events for QUARTET LDQT in NCT03640312"
        },
        {
          "reference" : "#NCT03640312-OtherAdverseEvents-EG001",
          "type" : "Evidence",
          "display" : "Other Adverse Events for Candesartan in NCT03640312"
        }
      ]
    },
    {
      "title" : "Serious Event List",
      "code" : {
        "text" : "SeriousEventList"
      },
      "section" : [
        {
          "title" : "Road Traffic Accident",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-0",
            "type" : "EvidenceVariable",
            "display" : "Road Traffic Accident as serious adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-SeriousAdverseEvent-0-EG000",
              "type" : "Evidence",
              "display" : "Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-SeriousAdverseEvent-0-EG001",
              "type" : "Evidence",
              "display" : "Road Traffic Accident as serious adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Chest Pain",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-SeriousAdverseEvent-1",
            "type" : "EvidenceVariable",
            "display" : "Chest Pain as serious adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-SeriousAdverseEvent-1-EG000",
              "type" : "Evidence",
              "display" : "Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-SeriousAdverseEvent-1-EG001",
              "type" : "Evidence",
              "display" : "Chest Pain as serious adverse event for Candesartan in NCT03640312"
            }
          ]
        }
      ]
    },
    {
      "title" : "Other Event List",
      "code" : {
        "text" : "OtherEventList"
      },
      "section" : [
        {
          "title" : "Vision blurred",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-0",
            "type" : "EvidenceVariable",
            "display" : "Vision blurred as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-0-EG000",
              "type" : "Evidence",
              "display" : "Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-0-EG001",
              "type" : "Evidence",
              "display" : "Vision blurred as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Palpitations",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-1",
            "type" : "EvidenceVariable",
            "display" : "Palpitations as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-1-EG000",
              "type" : "Evidence",
              "display" : "Palpitations as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-1-EG001",
              "type" : "Evidence",
              "display" : "Palpitations as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Tinnitus",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-2",
            "type" : "EvidenceVariable",
            "display" : "Tinnitus as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-2-EG000",
              "type" : "Evidence",
              "display" : "Tinnitus as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-2-EG001",
              "type" : "Evidence",
              "display" : "Tinnitus as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Eye pruritis",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-3",
            "type" : "EvidenceVariable",
            "display" : "Eye pruritis as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-3-EG000",
              "type" : "Evidence",
              "display" : "Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-3-EG001",
              "type" : "Evidence",
              "display" : "Eye pruritis as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Diarrhea",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-4",
            "type" : "EvidenceVariable",
            "display" : "Diarrhea as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-4-EG000",
              "type" : "Evidence",
              "display" : "Diarrhea as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-4-EG001",
              "type" : "Evidence",
              "display" : "Diarrhea as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Abdominal pain upper",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-5",
            "type" : "EvidenceVariable",
            "display" : "Abdominal pain upper as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-5-EG000",
              "type" : "Evidence",
              "display" : "Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-5-EG001",
              "type" : "Evidence",
              "display" : "Abdominal pain upper as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Dry Mouth",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-6",
            "type" : "EvidenceVariable",
            "display" : "Dry Mouth as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-6-EG000",
              "type" : "Evidence",
              "display" : "Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-6-EG001",
              "type" : "Evidence",
              "display" : "Dry Mouth as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Constipation",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-7",
            "type" : "EvidenceVariable",
            "display" : "Constipation as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-7-EG000",
              "type" : "Evidence",
              "display" : "Constipation as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-7-EG001",
              "type" : "Evidence",
              "display" : "Constipation as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Throat irritation",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-8",
            "type" : "EvidenceVariable",
            "display" : "Throat irritation as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-8-EG000",
              "type" : "Evidence",
              "display" : "Throat irritation as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-8-EG001",
              "type" : "Evidence",
              "display" : "Throat irritation as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Nausea",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-9",
            "type" : "EvidenceVariable",
            "display" : "Nausea as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-9-EG000",
              "type" : "Evidence",
              "display" : "Nausea as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-9-EG001",
              "type" : "Evidence",
              "display" : "Nausea as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Dry throat",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-10",
            "type" : "EvidenceVariable",
            "display" : "Dry throat as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-10-EG000",
              "type" : "Evidence",
              "display" : "Dry throat as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-10-EG001",
              "type" : "Evidence",
              "display" : "Dry throat as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Vomiting",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-11",
            "type" : "EvidenceVariable",
            "display" : "Vomiting as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-11-EG000",
              "type" : "Evidence",
              "display" : "Vomiting as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-11-EG001",
              "type" : "Evidence",
              "display" : "Vomiting as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Feeling Hot",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-12",
            "type" : "EvidenceVariable",
            "display" : "Feeling Hot as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-12-EG000",
              "type" : "Evidence",
              "display" : "Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-12-EG001",
              "type" : "Evidence",
              "display" : "Feeling Hot as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Influenza like illness",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-13",
            "type" : "EvidenceVariable",
            "display" : "Influenza like illness as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-13-EG000",
              "type" : "Evidence",
              "display" : "Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-13-EG001",
              "type" : "Evidence",
              "display" : "Influenza like illness as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Fatigue",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-14",
            "type" : "EvidenceVariable",
            "display" : "Fatigue as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-14-EG000",
              "type" : "Evidence",
              "display" : "Fatigue as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-14-EG001",
              "type" : "Evidence",
              "display" : "Fatigue as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Peripheral swelling",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-15",
            "type" : "EvidenceVariable",
            "display" : "Peripheral swelling as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-15-EG000",
              "type" : "Evidence",
              "display" : "Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-15-EG001",
              "type" : "Evidence",
              "display" : "Peripheral swelling as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Chest Pain",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-16",
            "type" : "EvidenceVariable",
            "display" : "Chest Pain as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-16-EG000",
              "type" : "Evidence",
              "display" : "Chest Pain as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-16-EG001",
              "type" : "Evidence",
              "display" : "Chest Pain as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Asthenia",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-17",
            "type" : "EvidenceVariable",
            "display" : "Asthenia as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-17-EG000",
              "type" : "Evidence",
              "display" : "Asthenia as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-17-EG001",
              "type" : "Evidence",
              "display" : "Asthenia as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Pain",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-18",
            "type" : "EvidenceVariable",
            "display" : "Pain as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-18-EG000",
              "type" : "Evidence",
              "display" : "Pain as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-18-EG001",
              "type" : "Evidence",
              "display" : "Pain as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Blood glucose increased",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-19",
            "type" : "EvidenceVariable",
            "display" : "Blood glucose increased as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-19-EG000",
              "type" : "Evidence",
              "display" : "Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-19-EG001",
              "type" : "Evidence",
              "display" : "Blood glucose increased as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Heart rate irregular",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-20",
            "type" : "EvidenceVariable",
            "display" : "Heart rate irregular as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-20-EG000",
              "type" : "Evidence",
              "display" : "Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-20-EG001",
              "type" : "Evidence",
              "display" : "Heart rate irregular as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Back pain",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-21",
            "type" : "EvidenceVariable",
            "display" : "Back pain as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-21-EG000",
              "type" : "Evidence",
              "display" : "Back pain as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-21-EG001",
              "type" : "Evidence",
              "display" : "Back pain as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Muscle cramps/spasms",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-22",
            "type" : "EvidenceVariable",
            "display" : "Muscle cramps/spasms as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-22-EG000",
              "type" : "Evidence",
              "display" : "Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-22-EG001",
              "type" : "Evidence",
              "display" : "Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Headache",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-23",
            "type" : "EvidenceVariable",
            "display" : "Headache as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-23-EG000",
              "type" : "Evidence",
              "display" : "Headache as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-23-EG001",
              "type" : "Evidence",
              "display" : "Headache as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Dizziness",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-24",
            "type" : "EvidenceVariable",
            "display" : "Dizziness as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-24-EG000",
              "type" : "Evidence",
              "display" : "Dizziness as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-24-EG001",
              "type" : "Evidence",
              "display" : "Dizziness as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Vision blurred",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-25",
            "type" : "EvidenceVariable",
            "display" : "Vision blurred as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-25-EG000",
              "type" : "Evidence",
              "display" : "Vision blurred as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-25-EG001",
              "type" : "Evidence",
              "display" : "Vision blurred as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Hypoaesthesia",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-26",
            "type" : "EvidenceVariable",
            "display" : "Hypoaesthesia as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-26-EG000",
              "type" : "Evidence",
              "display" : "Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-26-EG001",
              "type" : "Evidence",
              "display" : "Hypoaesthesia as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Anxiety",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-27",
            "type" : "EvidenceVariable",
            "display" : "Anxiety as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-27-EG000",
              "type" : "Evidence",
              "display" : "Anxiety as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-27-EG001",
              "type" : "Evidence",
              "display" : "Anxiety as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Nasopharyngitis",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-28",
            "type" : "EvidenceVariable",
            "display" : "Nasopharyngitis as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-28-EG000",
              "type" : "Evidence",
              "display" : "Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-28-EG001",
              "type" : "Evidence",
              "display" : "Nasopharyngitis as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Cough",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-29",
            "type" : "EvidenceVariable",
            "display" : "Cough as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-29-EG000",
              "type" : "Evidence",
              "display" : "Cough as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-29-EG001",
              "type" : "Evidence",
              "display" : "Cough as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Dyspnea",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-30",
            "type" : "EvidenceVariable",
            "display" : "Dyspnea as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-30-EG000",
              "type" : "Evidence",
              "display" : "Dyspnea as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-30-EG001",
              "type" : "Evidence",
              "display" : "Dyspnea as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Respiration Abnormal",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-31",
            "type" : "EvidenceVariable",
            "display" : "Respiration Abnormal as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-31-EG000",
              "type" : "Evidence",
              "display" : "Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-31-EG001",
              "type" : "Evidence",
              "display" : "Respiration Abnormal as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Hyperhidrosis",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-32",
            "type" : "EvidenceVariable",
            "display" : "Hyperhidrosis as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-32-EG000",
              "type" : "Evidence",
              "display" : "Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-32-EG001",
              "type" : "Evidence",
              "display" : "Hyperhidrosis as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Rash",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-33",
            "type" : "EvidenceVariable",
            "display" : "Rash as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-33-EG000",
              "type" : "Evidence",
              "display" : "Rash as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-33-EG001",
              "type" : "Evidence",
              "display" : "Rash as other adverse event for Candesartan in NCT03640312"
            }
          ]
        },
        {
          "title" : "Dizziness",
          "code" : {
            "coding" : [
              {
                "system" : "https://fevir.net/resources/CodeSystem/179423",
                "code" : "results",
                "display" : "Results"
              }
            ]
          },
          "focus" : {
            "reference" : "#NCT03640312-OtherAdverseEvent-34",
            "type" : "EvidenceVariable",
            "display" : "Dizziness as other adverse event"
          },
          "entry" : [
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-34-EG000",
              "type" : "Evidence",
              "display" : "Dizziness as other adverse event for QUARTET LDQT in NCT03640312"
            },
            {
              "reference" : "#NCT03640312-OtherAdverseEvent-34-EG001",
              "type" : "Evidence",
              "display" : "Dizziness as other adverse event for Candesartan in NCT03640312"
            }
          ]
        }
      ]
    }
  ]
}