Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

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

: Participant Flow Report for QUARTET USA Trial - XML Representation

Raw xml | Download


<Composition xmlns="http://hl7.org/fhir">
  <id value="370512"/>
  <meta>
    <versionId value="9"/>
    <lastUpdated value="2025-07-14T11:06:46.807Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-report"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition 370512</b></p><a name="370512"> </a><a name="hc370512"> </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: 9; Last updated: 2025-07-14 11:06:46+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-participant-flow-report.html">ParticipantFlowReport</a></p></div><p><b>Artifact Description</b>: </p><div><p>Example for EBMonFHIR IG</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/370512">https://fevir.net/resources/Composition/370512</a></p><p><b>identifier</b>: FEvIR Object Identifier/370512, FEvIR Linking Identifier/NCT03640312-participant-flow-report</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowReport}">Participant Flow Report</span></p><p><b>date</b>: 2025-07-14 11:06:46+0000</p><p><b>author</b>: Joanne Dehnbostel</p><p><b>title</b>: Participant Flow Report for QUARTET USA Trial</p><p><b>custodian</b>: <a href="Organization-118079.html">Computable Publishing LLC</a></p><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Cite As</p><p><b>target</b>: </p><div><p>Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-07-14. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/FLI/DocumentForComposition370512.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: Derived From</p><p><b>target</b>: <a href="Composition-370502.html">Participant Flow Report for NCT03640312</a></p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #ScreenedGroup</b></p><a name="370512/ScreenedGroup"> </a><a name="hc370512/ScreenedGroup"> </a><p><b>name</b>: Group Screened for Participation for QUARTET USA Trial</p><p><b>description</b>: </p><div><p>Potentially eligible patients screened for participation in the QUARTET USA Trial</p>
</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>quantity</b>: 120</p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #FG000</b></p><a name="370512/FG000"> </a><a name="hc370512/FG000"> </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">Profiles: <a href="StructureDefinition-comparator-group.html">ComparatorGroup</a>, <a href="StructureDefinition-exposure-group.html">ExposureGroup</a>, <a href="StructureDefinition-study-group.html">StudyGroup</a></p></div><p><b>name</b>: NCT03640312 Flow Group QUARTET LDQT</p><p><b>description</b>: </p><div><p>Patients randomized to the intervention arm took 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.</p>
<p>QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.</p>
</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>quantity</b>: 32</p><h3>Characteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Research Study from which this is a flow group</span></td><td>NCT03640312</td><td>false</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Group #FG001</b></p><a name="370512/FG001"> </a><a name="hc370512/FG001"> </a><p><b>name</b>: NCT03640312 Flow Group Candesartan</p><p><b>description</b>: </p><div><p>Patients randomized to the comparison arm took a once daily 8mg candesartan.</p>
<p>Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p>
</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>quantity</b>: 30</p><h3>Characteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Research Study from which this is a flow group</span></td><td>NCT03640312</td><td>false</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #ExcludedCount</b></p><a name="370512/ExcludedCount"> </a><a name="hc370512/ExcludedCount"> </a><p><b>title</b>: Excluded from QUARTET USA Trial</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Screened for Participation</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/ScreenedGroup">Screened for Participation</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Excluded</p>
</div><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: Excluded</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">count</span></td><td>58</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #ReasonsForExclusion</b></p><a name="370512/ReasonsForExclusion"> </a><a name="hc370512/ReasonsForExclusion"> </a><p><b>title</b>: Reasons for exclusion from QUARTET USA Trial</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Screened for Participation</p>
</div><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/ScreenedGroup">Screened for Participation</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Reasons for exclusion from QUARTET USA Trial</p>
</div><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="EvidenceVariable-372461.html">Reasons for exclusion from QUARTET USA Trial</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:{https://fevir.net/sevco STATO:0000047}">count</span></p><p><b>category</b>: <span title="Codes:">Not meeting inclusion criteria</span></p><p><b>quantity</b>: 56</p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:{https://fevir.net/sevco STATO:0000047}">count</span></p><p><b>category</b>: <span title="Codes:">Other reasons: &quot;no-shows&quot; for randomization</span></p><p><b>quantity</b>: 2</p></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-0-Overall-Study-group-FG000</b></p><a name="370512/NCT03640312-flow-milestone-0-Overall-Study-group-FG000"> </a><a name="hc370512/NCT03640312-flow-milestone-0-Overall-Study-group-FG000"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-0-Overall-Study-group-FG000</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG000">QUARTET LDQT</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: STARTED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>32</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-0-Overall-Study-group-FG001</b></p><a name="370512/NCT03640312-flow-milestone-0-Overall-Study-group-FG001"> </a><a name="hc370512/NCT03640312-flow-milestone-0-Overall-Study-group-FG001"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-0-Overall-Study-group-FG001</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG001">Candesartan</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: STARTED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>30</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG000</b></p><a name="370512/NCT03640312-flow-milestone-1-Overall-Study-group-FG000"> </a><a name="hc370512/NCT03640312-flow-milestone-1-Overall-Study-group-FG000"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-1-Overall-Study-group-FG000</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG000">QUARTET LDQT</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: 6 Week Follow Up at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>32</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-1-Overall-Study-group-FG001</b></p><a name="370512/NCT03640312-flow-milestone-1-Overall-Study-group-FG001"> </a><a name="hc370512/NCT03640312-flow-milestone-1-Overall-Study-group-FG001"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-1-Overall-Study-group-FG001</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG001">Candesartan</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: 6 Week Follow Up at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>28</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG000</b></p><a name="370512/NCT03640312-flow-milestone-2-Overall-Study-group-FG000"> </a><a name="hc370512/NCT03640312-flow-milestone-2-Overall-Study-group-FG000"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-2-Overall-Study-group-FG000</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG000">QUARTET LDQT</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: COMPLETED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>29</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-2-Overall-Study-group-FG001</b></p><a name="370512/NCT03640312-flow-milestone-2-Overall-Study-group-FG001"> </a><a name="hc370512/NCT03640312-flow-milestone-2-Overall-Study-group-FG001"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-2-Overall-Study-group-FG001</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG001">Candesartan</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: COMPLETED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>24</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG000</b></p><a name="370512/NCT03640312-flow-milestone-3-Overall-Study-group-FG000"> </a><a name="hc370512/NCT03640312-flow-milestone-3-Overall-Study-group-FG000"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-3-Overall-Study-group-FG000</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG000">QUARTET LDQT</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: NOT COMPLETED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>3</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-milestone-3-Overall-Study-group-FG001</b></p><a name="370512/NCT03640312-flow-milestone-3-Overall-Study-group-FG001"> </a><a name="hc370512/NCT03640312-flow-milestone-3-Overall-Study-group-FG001"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-milestone-3-Overall-Study-group-FG001</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG001">Candesartan</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: NOT COMPLETED at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td>6</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG000</b></p><a name="370512/NCT03640312-flow-reason-Overall-Study-group-FG000"> </a><a name="hc370512/NCT03640312-flow-reason-Overall-Study-group-FG000"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-reason-Overall-Study-group-FG000</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG000">QUARTET LDQT</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: Reasons for withdraw at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Category</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td><span title="Codes:">Lost to Follow-up</span></td><td>3</td></tr></table></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Evidence #NCT03640312-flow-reason-Overall-Study-group-FG001</b></p><a name="370512/NCT03640312-flow-reason-Overall-Study-group-FG001"> </a><a name="hc370512/NCT03640312-flow-reason-Overall-Study-group-FG001"> </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-participant-flow-evidence.html">ParticipantFlowEvidence</a></p></div><p><b>identifier</b>: FEvIR Linking Identifier/NCT03640312-flow-reason-Overall-Study-group-FG001</p><p><b>title</b>: ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study</p><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="CodeSystem-179423.html#179423-evidence-communication">Evidence Based Medicine on FHIR Implementation Guide Code System evidence-communication</a>: Evidence Communication</td><td><span title="Codes:{https://fevir.net/resources/CodeSystem/179423 ParticipantFlowEvidence}">ParticipantFlowEvidence</span></td></tr></table><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href="#hc370512/FG001">Candesartan</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: Reasons for withdraw at Overall Study</p></blockquote><h3>Statistics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>StatisticType</b></td><td><b>Category</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count</span></td><td><span title="Codes:">Lost to Follow-up</span></td><td>6</td></tr></table></blockquote></div>
  </text>
  <contained>
    <Group>
      <id value="ScreenedGroup"/>
      <name value="Group Screened for Participation for QUARTET USA Trial"/>
      <description
                   value="Potentially eligible patients screened for participation in the QUARTET USA Trial"/>
      <type value="person"/>
      <membership value="enumerated"/>
      <quantity value="120"/>
    </Group>
  </contained>
  <contained>
    <Group>
      <id value="FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparator-group"/>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"/>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/study-group"/>
      </meta>
      <name value="NCT03640312 Flow Group QUARTET LDQT"/>
      <description
                   value="Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.

QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks."/>
      <type value="person"/>
      <membership value="enumerated"/>
      <quantity value="32"/>
      <characteristic>
        <code>
          <text value="Research Study from which this is a flow group"/>
        </code>
        <valueReference>
          <display value="NCT03640312"/>
        </valueReference>
        <exclude value="false"/>
      </characteristic>
    </Group>
  </contained>
  <contained>
    <Group>
      <id value="FG001"/>
      <name value="NCT03640312 Flow Group Candesartan"/>
      <description
                   value="Patients randomized to the comparison arm took a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
      <type value="person"/>
      <membership value="enumerated"/>
      <quantity value="30"/>
      <characteristic>
        <code>
          <text value="Research Study from which this is a flow group"/>
        </code>
        <valueReference>
          <display value="NCT03640312"/>
        </valueReference>
        <exclude value="false"/>
      </characteristic>
    </Group>
  </contained>
  <contained>
    <Evidence>
      <id value="ExcludedCount"/>
      <title value="Excluded from QUARTET USA Trial"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Screened for Participation"/>
        <variableRole value="population"/>
        <observed>
          <reference value="#ScreenedGroup"/>
          <type value="Group"/>
          <display value="Screened for Participation"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <description value="Excluded"/>
        <variableRole value="outcome"/>
        <observed>
          <type value="EvidenceVariable"/>
          <display value="Excluded"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="58"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="ReasonsForExclusion"/>
      <title value="Reasons for exclusion from QUARTET USA Trial"/>
      <status value="active"/>
      <variableDefinition>
        <description value="Screened for Participation"/>
        <variableRole value="population"/>
        <observed>
          <reference value="#ScreenedGroup"/>
          <type value="Group"/>
          <display value="Screened for Participation"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <description value="Reasons for exclusion from QUARTET USA Trial"/>
        <variableRole value="outcome"/>
        <observed>🔗 
          <reference value="EvidenceVariable/372461"/>
          <type value="EvidenceVariable"/>
          <display value="Reasons for exclusion from QUARTET USA Trial"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="count"/>
          </coding>
        </statisticType>
        <category>
          <text value="Not meeting inclusion criteria"/>
        </category>
        <quantity>
          <value value="56"/>
        </quantity>
      </statistic>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="count"/>
          </coding>
        </statisticType>
        <category>
          <text
                value="Other reasons: &quot;no-shows&quot; for randomization"/>
        </category>
        <quantity>
          <value value="2"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-0-Overall-Study-group-FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-0-Overall-Study-group-FG000"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG000"/>
          <type value="Group"/>
          <display value="QUARTET LDQT"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="STARTED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="32"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-0-Overall-Study-group-FG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-0-Overall-Study-group-FG001"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG001"/>
          <type value="Group"/>
          <display value="Candesartan"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="STARTED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="30"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-1-Overall-Study-group-FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-1-Overall-Study-group-FG000"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG000"/>
          <type value="Group"/>
          <display value="QUARTET LDQT"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="6 Week Follow Up at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="32"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-1-Overall-Study-group-FG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-1-Overall-Study-group-FG001"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG001"/>
          <type value="Group"/>
          <display value="Candesartan"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="6 Week Follow Up at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="28"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-2-Overall-Study-group-FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-2-Overall-Study-group-FG000"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG000"/>
          <type value="Group"/>
          <display value="QUARTET LDQT"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="COMPLETED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="29"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-2-Overall-Study-group-FG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-2-Overall-Study-group-FG001"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG001"/>
          <type value="Group"/>
          <display value="Candesartan"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="COMPLETED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="24"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-3-Overall-Study-group-FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-3-Overall-Study-group-FG000"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG000"/>
          <type value="Group"/>
          <display value="QUARTET LDQT"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="NOT COMPLETED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="3"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-milestone-3-Overall-Study-group-FG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value
               value="NCT03640312-flow-milestone-3-Overall-Study-group-FG001"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG001"/>
          <type value="Group"/>
          <display value="Candesartan"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="NOT COMPLETED at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <quantity>
          <value value="6"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-reason-Overall-Study-group-FG000"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value value="NCT03640312-flow-reason-Overall-Study-group-FG000"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG000"/>
          <type value="Group"/>
          <display value="QUARTET LDQT"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="Reasons for withdraw at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <category>
          <text value="Lost to Follow-up"/>
        </category>
        <quantity>
          <value value="3"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <contained>
    <Evidence>
      <id value="NCT03640312-flow-reason-Overall-Study-group-FG001"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"/>
      </meta>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value value="NCT03640312-flow-reason-Overall-Study-group-FG001"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <title
             value="ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study"/>
      <status value="active"/>
      <author>
        <name
              value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
      </author>
      <useContext>
        <code>
          <system value="https://fevir.net/resources/CodeSystem/179423"/>
          <code value="evidence-communication"/>
          <display value="Evidence Communication"/>
        </code>
        <valueCodeableConcept>
          <coding>
            <system value="https://fevir.net/resources/CodeSystem/179423"/>
            <code value="ParticipantFlowEvidence"/>
            <display value="ParticipantFlowEvidence"/>
          </coding>
        </valueCodeableConcept>
      </useContext>
      <variableDefinition>
        <variableRole value="population"/>
        <observed>
          <reference value="#FG001"/>
          <type value="Group"/>
          <display value="Candesartan"/>
        </observed>
      </variableDefinition>
      <variableDefinition>
        <variableRole value="outcome"/>
        <observed>
          <display value="Reasons for withdraw at Overall Study"/>
        </observed>
      </variableDefinition>
      <statistic>
        <statisticType>
          <coding>
            <system value="https://fevir.net/sevco"/>
            <code value="STATO:0000047"/>
            <display value="Count"/>
          </coding>
        </statisticType>
        <category>
          <text value="Lost to Follow-up"/>
        </category>
        <quantity>
          <value value="6"/>
        </quantity>
      </statistic>
    </Evidence>
  </contained>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/artifact-description">
    <valueMarkdown value="Example for EBMonFHIR IG"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status">
    <valueCodeableConcept>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"/>
        <code value="active"/>
        <display value="Active"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <url value="https://fevir.net/resources/Composition/370512"/>
  <identifier>
    <type>
      <coding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
        <code value="ACSN"/>
        <display value="Accession ID"/>
      </coding>
      <text value="FEvIR Object Identifier"/>
    </type>
    <system value="https://fevir.net/FOI"/>
    <value value="370512"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <type>
      <text value="FEvIR Linking Identifier"/>
    </type>
    <system value="https://fevir.net/FLI"/>
    <value value="NCT03640312-participant-flow-report"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <status value="final"/>
  <type>
    <coding>
      <system value="https://fevir.net/resources/CodeSystem/179423"/>
      <code value="ParticipantFlowReport"/>
      <display value="ParticipantFlowReport"/>
    </coding>
    <text value="Participant Flow Report"/>
  </type>
  <date value="2025-07-14T11:06:46.807Z"/>
  <author>
    <display value="Joanne Dehnbostel"/>
  </author>
  <title value="Participant Flow Report for QUARTET USA Trial"/>
  <custodian>🔗 
    <reference value="Organization/118079"/>
    <type value="Organization"/>
    <display value="Computable Publishing LLC"/>
  </custodian>
  <relatesTo>
    <type value="cite-as"/>
    <targetMarkdown
                    value="Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-07-14. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/FLI/DocumentForComposition370512."/>
  </relatesTo>
  <relatesTo>
    <type value="derived-from"/>
    <targetReference>🔗 
      <reference value="Composition/370502"/>
      <type value="Composition"/>
      <display value="Participant Flow Report for NCT03640312"/>
    </targetReference>
  </relatesTo>
  <section>
    <title value="Excluded"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>
      <type value="EvidenceVariable"/>
      <display value="Excluded"/>
    </focus>
    <entry>
      <reference value="#ExcludedCount"/>
      <type value="Evidence"/>
      <display value="Excluded from QUARTET USA Trial"/>
    </entry>
  </section>
  <section>
    <title value="Reasons for exclusion"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
    </code>
    <focus>🔗 
      <reference value="EvidenceVariable/372461"/>
      <type value="EvidenceVariable"/>
      <display value="Reasons for exclusion from QUARTET USA Trial"/>
    </focus>
    <entry>
      <reference value="#ReasonsForExclusion"/>
      <type value="Evidence"/>
      <display value="Reasons for exclusion from QUARTET USA Trial"/>
    </entry>
  </section>
  <section>
    <title value="Flow PreAssignment Details"/>
    <code>
      <text value="FlowPreAssignmentDetails"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">NA - all enrolled participants were randomized.</div>
    </text>
  </section>
  <section>
    <title value="Flow Recruitment Details"/>
    <code>
      <text value="FlowRecruitmentDetails"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized</div>
    </text>
  </section>
  <section>
    <title value="Flow Group List"/>
    <code>
      <text value="FlowGroupList"/>
    </code>
    <text>
      <status value="generated"/>
      <div xmlns="http://www.w3.org/1999/xhtml">QUARTET LDQT, Candesartan</div>
    </text>
    <entry>
      <reference value="#ScreenedGroup"/>
      <type value="Group"/>
      <display value="Screened for Participation"/>
    </entry>
    <entry>
      <reference value="#FG000"/>
      <type value="Group"/>
      <display value="QUARTET LDQT"/>
    </entry>
    <entry>
      <reference value="#FG001"/>
      <type value="Group"/>
      <display value="Candesartan"/>
    </entry>
  </section>
  <section>
    <title value="STARTED at Overall Study"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Participant Flow Results"/>
    </code>
    <focus>
      <display value="STARTED at Overall Study"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-0-Overall-Study-group-FG000"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study"/>
    </entry>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-0-Overall-Study-group-FG001"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study"/>
    </entry>
  </section>
  <section>
    <title value="6 Week Follow Up at Overall Study"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Participant Flow Results"/>
    </code>
    <focus>
      <display value="6 Week Follow Up at Overall Study"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-1-Overall-Study-group-FG000"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study"/>
    </entry>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-1-Overall-Study-group-FG001"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study"/>
    </entry>
  </section>
  <section>
    <title value="COMPLETED at Overall Study"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Participant Flow Results"/>
    </code>
    <focus>
      <display value="COMPLETED at Overall Study"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-2-Overall-Study-group-FG000"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study"/>
    </entry>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-2-Overall-Study-group-FG001"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study"/>
    </entry>
  </section>
  <section>
    <title value="NOT COMPLETED at Overall Study"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Participant Flow Results"/>
    </code>
    <focus>
      <display value="NOT COMPLETED at Overall Study"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-3-Overall-Study-group-FG000"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study"/>
    </entry>
    <entry>
      <reference
                 value="#NCT03640312-flow-milestone-3-Overall-Study-group-FG001"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study"/>
    </entry>
  </section>
  <section>
    <title value="Reasons for withdraw at Overall Study"/>
    <code>
      <coding>
        <system value="https://fevir.net/resources/CodeSystem/179423"/>
        <code value="results"/>
        <display value="Results"/>
      </coding>
      <text value="Participant Flow Results"/>
    </code>
    <focus>
      <display value="Reasons for withdraw at Overall Study"/>
    </focus>
    <text>
      <status value="empty"/>
      <div xmlns="http://www.w3.org/1999/xhtml"><p>[No data.]</p></div>
    </text>
    <entry>
      <reference value="#NCT03640312-flow-reason-Overall-Study-group-FG000"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study"/>
    </entry>
    <entry>
      <reference value="#NCT03640312-flow-reason-Overall-Study-group-FG001"/>
      <type value="Evidence"/>
      <display
               value="ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study"/>
    </entry>
  </section>
</Composition>