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 - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Composition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "399866"] ; #
fhir:meta [
fhir:versionId [ fhir:v "2" ] ;
fhir:lastUpdated [ fhir:v "2025-09-14T18:15:51.793Z"^^xsd:dateTime ] ;
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-narratives> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<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>"^^rdf:XMLLiteral
] ; #
fhir:url [ fhir:v "https://fevir.net/resources/Composition/399866"^^xsd:anyURI] ; #
fhir:identifier ( [
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ] ;
fhir:code [ fhir:v "ACSN" ] ;
fhir:display [ fhir:v "Accession ID" ] ] ) ;
fhir:text [ fhir:v "FEvIR Object Identifier" ] ] ;
fhir:system [ fhir:v "https://fevir.net/FOI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "399866" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ] ]
] ) ; #
fhir:status [ fhir:v "final"] ; #
fhir:type [
( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/CodeSystem/narrative-elements-cs"^^xsd:anyURI ] ;
fhir:code [ fhir:v "b001" ] ;
fhir:display [ fhir:v "Protocol narrative" ] ] )
] ; #
fhir:subject ( [
fhir:reference [ fhir:v "ResearchStudy/399864" ] ;
fhir:type [ fhir:v "ResearchStudy"^^xsd:anyURI ] ;
fhir:display [ fhir:v "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)" ]
] ) ; #
fhir:date [ fhir:v "2025-09-14T18:15:51.793Z"^^xsd:dateTime] ; #
fhir:author ( [
fhir:reference [ fhir:v "Organization/399869" ] ;
fhir:type [ fhir:v "Organization"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Eli Lilly Japan K.K (399869)" ]
] ) ; #
fhir:title [ fhir:v "IGBJ Protocol Narrative 2.1"] ; #
fhir:custodian [
fhir:reference [ fhir:v "Organization/118079" ] ;
fhir:type [ fhir:v "Organization"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Computable Publishing LLC" ]
] ; #
fhir:relatesTo ( [
fhir:type [ fhir:v "cite-as" ] ;
fhir:target [
a fhir:markdown ;
fhir:v "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." ]
] ) ; #
fhir:section ( [
fhir:title [ fhir:v "2.1 Purpose of Trial" ] ;
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218521" ] ] ) ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<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>"^^rdf:XMLLiteral ]
] ) . #
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