Outcome Measures Report for NCT03421379 - XML Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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
: Outcome Measures Report for NCT03421379

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    <div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><p class="res-header-id"><b>Generated Narrative: Composition 399873</b></p><a name="399873"> </a><a name="hc399873"> </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: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-outcome-measure-report.html">OutcomeMeasureReport</a></p></div><p><b>url</b>: <a href="https://fevir.net/resources/Composition/399873">https://fevir.net/resources/Composition/399873</a></p><p><b>identifier</b>: FEvIR Object Identifier/399873, FEvIR Linking Identifier/NCT03421379-outcome-measure-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>: 2025-12-11 20:35:21+0000</p><p><b>author</b>: [No author listed.]</p><p><b>title</b>: Outcome Measures Report for NCT03421379</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>Outcome Measures Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399873. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399873. Computable resource at: https://fevir.net/resources/Composition/399873#json.</p>
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        <title
               value="Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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        <title
               value="PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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           value="Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration"/>
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          <div xmlns="http://www.w3.org/1999/xhtml">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>
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        <entry>
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    </section>
    <section>
      <title value="Outcome Class List"/>
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        <text value="OutcomeClassList"/>
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      <section>
        <title
               value="Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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            <value value="NCT03421379-secondaryOutcome-2"/>
            <assigner>
              <display value="Computable Publishing LLC"/>
            </assigner>
          </identifier>
          <display
                   value="Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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              <display value="Computable Publishing LLC"/>
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          <display
                   value="Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379"/>
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          <display
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  </section>
  <section>
    <title
           value="PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration"/>
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        <value value="NCT03421379-secondaryOutcome-3"/>
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          <display value="Computable Publishing LLC"/>
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      <display
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      <title value="Outcome Measure Population Description"/>
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        <text value="OutcomeMeasurePopulationDescription"/>
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        <div xmlns="http://www.w3.org/1999/xhtml">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>
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        <text value="OutcomeMeasureReportingStatus"/>
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        <div xmlns="http://www.w3.org/1999/xhtml">Posted</div>
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        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>
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    <section>
      <title value="Outcome Group List"/>
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        <text value="OutcomeGroupList"/>
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        <title value="Glucagon Nasal Powder"/>
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          <text value="OG000"/>
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          <text value="OG001"/>
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          <div xmlns="http://www.w3.org/1999/xhtml">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>
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        <entry>
          <display
                   value="A single dose of 1 mg glucagon hydrochloride solution was administered IM"/>
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      <title value="Outcome Class List"/>
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        <text value="OutcomeClassList"/>
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      <section>
        <title
               value="PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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            <value value="NCT03421379-secondaryOutcome-3"/>
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              <display value="Computable Publishing LLC"/>
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          </identifier>
          <display
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        <entry>🔗 
          <reference value="Evidence/267240"/>
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            <value value="NCT03421379-secondaryOutcomeMeasure-3--OG000"/>
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              <display value="Computable Publishing LLC"/>
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          <display
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          <display
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  </section>
  <section>
    <title
           value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration"/>
    <focus>🔗 
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          <text value="FEvIR Linking Identifier"/>
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        <system value="https://fevir.net/FLI"/>
        <value value="NCT03421379-secondaryOutcome-4"/>
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      <display
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        <text value="OutcomeMeasurePopulationDescription"/>
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        <div xmlns="http://www.w3.org/1999/xhtml">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>
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        <div xmlns="http://www.w3.org/1999/xhtml">Posted</div>
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        <div xmlns="http://www.w3.org/1999/xhtml">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>
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        <text value="OutcomeGroupList"/>
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        <title value="Glucagon Nasal Powder"/>
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          <text value="OG000"/>
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          <text value="OG001"/>
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          <display
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        <text value="OutcomeClassList"/>
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        <title
               value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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          <reference value="EvidenceVariable/267231"/>
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            <value value="NCT03421379-secondaryOutcome-4"/>
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              <display value="Computable Publishing LLC"/>
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          <display
                   value="PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)"/>
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              <display value="Computable Publishing LLC"/>
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          <display
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          <reference value="Evidence/267243"/>
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          <display
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    </section>
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</Composition>