Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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-ballot3 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

: Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

Page standards status: Informative

Raw xml | Download


<Evidence xmlns="http://hl7.org/fhir">
  <id value="367947"/>
  <meta>
    <versionId value="30"/>
    <lastUpdated value="2026-09-08T12:21:25.982Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"/>
  </meta>
  <language value="en"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Evidence 367947</b></p><a name="367947"> </a><a name="hc367947"> </a><div style="display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 30; Last updated: 2026-09-08 12:21:25+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-comparative-evidence.html">ComparativeEvidence</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="Evidence-367947.html">Evidence Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</a></p><p><b>identifier</b>: FEvIR Object Identifier/367947, FEvIR Linking Identifier/NCT03640312-secondaryOutcomeMeasure-5-OutcomeAnalysis-6-BetweenGroupAnalysis-OG000-OG001, <a href="http://terminology.hl7.org/7.5.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt 

This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: 

Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.

This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.22.259</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: NCT03640312_secondaryOutcomeMeasure_5_OutcomeAnalysis_6_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367947. Revised 2026-09-08. Available at: https://fevir.net/resources/Evidence/367947. Computable resource at: https://fevir.net/resources/Evidence/367947#json.</p>
</div><p><b>status</b>: Active</p><p><b>date</b>: 2026-11-05 14:34:28+0000</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>
</div><p><b>description</b>: </p><div><p>Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects.</p>
</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.</p>
</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href="Group-367881.html">NCT03640312 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: QUARTET LDQT vs. Candesartan</p>
</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Candesartan</p><p><b>observed</b>: Group Assignment: 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. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="EvidenceVariable-367888.html">Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Superiority</p>
</div></blockquote><p><b>statisticType</b>: <span title="Codes:">Odds Ratio (OR)</span></p><p><b>quantity</b>: 0.8</p><blockquote><p><b>attributeEstimate</b></p><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C44185}">P-value</span></p><p><b>quantity</b>: 0.71</p></blockquote><blockquote><p><b>attributeEstimate</b></p><p><b>note</b>: </p><blockquote><div><p>CI Number of Sides: 2-Sided</p>
</div></blockquote><p><b>type</b>: <span title="Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}">Confidence interval</span></p><p><b>level</b>: 0.95</p><p><b>range</b>: 0.24-2.69</p></blockquote><h3>ModelCharacteristics</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Mixed Models Analysis</span></td></tr></table></blockquote></div>
  </text>
  <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/Evidence/367947"/>
  <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="367947"/>
    <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-secondaryOutcomeMeasure-5-OutcomeAnalysis-6-BetweenGroupAnalysis-OG000-OG001"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <identifier>
    <system value="urn:ietf:rfc:3986"/>
    <value value="urn:oid:2.16.840.1.113883.4.642.40.44.22.259"/>
  </identifier>
  <version value="1.0.0-ballot3"/>
  <name
        value="NCT03640312_secondaryOutcomeMeasure_5_OutcomeAnalysis_6_BetweenGroupAnalysis_OG000_OG001"/>
  <title
         value="Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312"/>
  <citeAs
          value="Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367947. Revised 2026-09-08. Available at: https://fevir.net/resources/Evidence/367947. Computable resource at: https://fevir.net/resources/Evidence/367947#json."/>
  <status value="active"/>
  <date value="2026-11-05T14:34:28+00:00"/>
  <author>
    <name
          value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
  </author>
  <publisher value="HL7 International / Clinical Decision Support"/>
  <contact>
    <name value="HL7 International / Clinical Decision Support"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/dss"/>
    </telecom>
  </contact>
  <copyright
             value="Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse)."/>
  <description
               value="Generalized linear mixed model adjusting for baseline systolic and diastolic blood pressure. Random participant effects. Fixed baseline systolic, diastolic, study arm, and time effects."/>
  <variableDefinition>
    <note>
      <text
            value="Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol."/>
    </note>
    <variableRole value="population"/>
    <intended>🔗 
      <reference value="Group/367881"/>
      <type value="Group"/>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value value="NCT03640312 Eligibility Criteria"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
    </intended>
  </variableDefinition>
  <variableDefinition>
    <description value="Group Assignment: QUARTET LDQT vs. Candesartan"/>
    <variableRole value="exposure"/>
    <comparatorCategory value="Candesartan"/>
    <observed>
      <display
               value="Group Assignment: 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. vs. Patients randomized to the comparison arm took a once daily 8mg candesartan.

Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks."/>
    </observed>
  </variableDefinition>
  <variableDefinition>
    <variableRole value="outcome"/>
    <observed>🔗 
      <reference value="EvidenceVariable/367888"/>
      <type value="EvidenceVariable"/>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value value="NCT03640312-secondaryOutcome-5"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <display
               value="Proportion of Patients With Adverse Event Free Hypertension Control at 12 weeks (NCT03640312)"/>
    </observed>
  </variableDefinition>
  <statistic>
    <note>
      <text value="Outcome Analysis NonInferiority Type: Superiority"/>
    </note>
    <statisticType>
      <text value="Odds Ratio (OR)"/>
    </statisticType>
    <quantity>
      <value value="0.8"/>
    </quantity>
    <attributeEstimate>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
          <code value="C44185"/>
          <display value="P-value"/>
        </coding>
      </type>
      <quantity>
        <value value="0.71"/>
      </quantity>
    </attributeEstimate>
    <attributeEstimate>
      <note>
        <text value="CI Number of Sides: 2-Sided"/>
      </note>
      <type>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/attribute-estimate-type"/>
          <code value="C53324"/>
          <display value="Confidence interval"/>
        </coding>
      </type>
      <level value="0.95"/>
      <range>
        <low>
          <value value="0.24"/>
        </low>
        <high>
          <value value="2.69"/>
        </high>
      </range>
    </attributeEstimate>
    <modelCharacteristic>
      <code>
        <text value="Mixed Models Analysis"/>
      </code>
    </modelCharacteristic>
  </statistic>
</Evidence>