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

: Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312 - XML Representation

Raw xml | Download


<Evidence xmlns="http://hl7.org/fhir">
  <id value="367931"/>
  <meta>
    <versionId value="26"/>
    <lastUpdated value="2025-08-18T13:22:42.074Z"/>
    <profile
             value="http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Evidence 367931</b></p><a name="367931"> </a><a name="hc367931"> </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: 26; Last updated: 2025-08-18 13:22:42+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-non-comparative-evidence.html">NonComparativeEvidence</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/Evidence/367931">https://fevir.net/resources/Evidence/367931</a></p><p><b>identifier</b>: FEvIR Object Identifier/367931, FEvIR Linking Identifier/NCT03640312-otherOutcomeMeasure-2--OG000</p><p><b>name</b>: NCT03640312_otherOutcomeMeasure_2_OG000</p><p><b>title</b>: Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312</p><p><b>citeAs</b>: </p><div><p>Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT 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 367931. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367931. Computable resource at: https://fevir.net/resources/Evidence/367931#json.</p>
</div><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href="mailto:support@computablepublishing.com">support@computablepublishing.com</a></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>QUARTET LDQT</p>
</div><p><b>note</b>: </p><blockquote><div><p>Outcome Measure Denominator Units: Participants</p>
</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: 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. (Identifier: ClinicalTrials.gov Outcome Measurement Group Id/OG000)</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href="EvidenceVariable-367898.html">Rate of Adverse Events of Special Interest at 12 weeks -  (NCT03640312)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title="Codes:{https://fevir.net/sevco STATO:0000047}">Count of Participants</span></p><p><b>quantity</b>: 16 Participants</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><h3>AttributeEstimates</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:">Percentage</span></td><td>50 %</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/367931"/>
  <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="367931"/>
    <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-otherOutcomeMeasure-2--OG000"/>
    <assigner>
      <display value="Computable Publishing LLC"/>
    </assigner>
  </identifier>
  <name value="NCT03640312_otherOutcomeMeasure_2_OG000"/>
  <title
         value="Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312"/>
  <citeAs
          value="Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT 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 367931. Revised 2025-08-18. Available at: https://fevir.net/resources/Evidence/367931. Computable resource at: https://fevir.net/resources/Evidence/367931#json."/>
  <status value="active"/>
  <author>
    <name
          value="Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"/>
  </author>
  <publisher value="Computable Publishing LLC"/>
  <contact>
    <telecom>
      <system value="email"/>
      <value value="support@computablepublishing.com"/>
    </telecom>
  </contact>
  <copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
  <description
               value="This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide."/>
  <variableDefinition>
    <description value="QUARTET LDQT"/>
    <note>
      <text value="Outcome Measure Denominator Units: Participants"/>
    </note>
    <variableRole value="population"/>
    <observed>
      <identifier>
        <type>
          <text value="ClinicalTrials.gov Outcome Measurement Group Id"/>
        </type>
        <value value="OG000"/>
      </identifier>
      <display
               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."/>
    </observed>
  </variableDefinition>
  <variableDefinition>
    <variableRole value="outcome"/>
    <observed>🔗 
      <reference value="EvidenceVariable/367898"/>
      <type value="EvidenceVariable"/>
      <identifier>
        <type>
          <text value="FEvIR Linking Identifier"/>
        </type>
        <system value="https://fevir.net/FLI"/>
        <value value="NCT03640312-otherOutcome-2"/>
        <assigner>
          <display value="Computable Publishing LLC"/>
        </assigner>
      </identifier>
      <display
               value="Rate of Adverse Events of Special Interest at 12 weeks -  (NCT03640312)"/>
    </observed>
  </variableDefinition>
  <statistic>
    <statisticType>
      <coding>
        <system value="https://fevir.net/sevco"/>
        <code value="STATO:0000047"/>
        <display value="count"/>
      </coding>
      <text value="Count of Participants"/>
    </statisticType>
    <quantity>
      <value value="16"/>
      <unit value="Participants"/>
    </quantity>
    <sampleSize>
      <knownDataCount value="32"/>
    </sampleSize>
    <attributeEstimate>
      <type>
        <text value="Percentage"/>
      </type>
      <quantity>
        <value value="50"/>
        <unit value="%"/>
      </quantity>
    </attributeEstimate>
  </statistic>
</Evidence>