Evidence Based Medicine on FHIR Implementation Guide
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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

: IGBJ Protocol Narrative 2.1 - XML Representation

Page standards status: Informative

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<Composition xmlns="http://hl7.org/fhir">
  <id value="399866"/>
  <meta>
    <versionId value="2"/>
    <lastUpdated value="2025-09-14T18:15:51.793Z"/>
    <profile
             value="http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition IGBJ-Narrative-2.1</b></p><a name="IGBJ-Narrative-2.1"> </a><a name="hcIGBJ-Narrative-2.1"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px"/><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-m11-research-study-narratives.html">Research Study Narratives</a></p></div><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs b001}">Protocol narrative</span></p><p><b>date</b>: 2025-06-03 12:46:00+0000</p><p><b>author</b>: <a href="Organization-IGBJ-Organization.html">Organization Eli Lilly Japan K.K</a></p><p><b>title</b>: IGBJ Protocol Narrative 2.1</p></div>
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        <display value="Accession ID"/>
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      <text value="FEvIR Object Identifier"/>
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              value="http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs"/>
      <code value="b001"/>
      <display value="Protocol narrative"/>
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  </type>
  <subject>🔗 
    <reference value="ResearchStudy/399864"/>
    <type value="ResearchStudy"/>
    <display
             value="A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus (399864)"/>
  </subject>
  <date value="2025-09-14T18:15:51.793Z"/>
  <author>🔗 
    <reference value="Organization/399869"/>
    <type value="Organization"/>
    <display value="Eli Lilly Japan K.K (399869)"/>
  </author>
  <title value="IGBJ Protocol Narrative 2.1"/>
  <custodian>🔗 
    <reference value="Organization/118079"/>
    <type value="Organization"/>
    <display value="Computable Publishing LLC"/>
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  <relatesTo>
    <type value="cite-as"/>
    <targetMarkdown
                    value="IGBJ Protocol Narrative 2.1 [Database Entry: FHIR Composition Resource]. Contributors: Eli Lilly Japan K.K (399869) [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399866. Revised 2025-09-14. Available at: https://fevir.net/resources/Composition/399866. Computable resource at: https://fevir.net/resources/Composition/399866#json."/>
  </relatesTo>
  <section>
    <title value="2.1 Purpose of Trial"/>
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      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C218521"/>
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    <text>
      <status value="additional"/>
      <div xmlns="http://www.w3.org/1999/xhtml">|1. have had a diagnosis of either:| |a. T1DM based on the World Health Organization (WHO) diagnostic criteria, and have been on the following daily insulin therapy for at least 1 year ​ i. multiple daily injection of long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) and rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine), or ​ ii. continuous subcutaneous insulin infusion (CSII) | |**Or** b. T2DM based on the WHO diagnostic criteria, and have received the following daily insulin therapy with or without oral anti-hyperglycemic medications (OAMs) for at least 1 year ​ i. insulin: long-acting insulin analog (either insulin glargine [U-100 or U-300] or insulin degludec [U-100]) alone, or in combination with rapid-acting insulin analog (insulin lispro, insulin aspart, or insulin glulisine) or CSII ​ ii. OAM: up to 3 of the following OAMs in accordance with local regulations: metformin, dipeptidyl peptidase-4 inhibitor, sodium glucose cotransporter 2 inhibitor, sulfonylurea (should not be more than half of maximum approved doses), glinides, alpha-glucosidase inhibitor, or thiazolidine | | tabl title | | ---------- | | row 1 | | row 2 | | row 3 |</div>
    </text>
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