M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example - TTL 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
: M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@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 -------------------------------------------------------------------

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fhir:code [ fhir:v "C218530" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]           ] )         ] ;
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fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-4" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]         ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG</p><p>Secondary objective description: PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]         ] ;
        ( fhir:entry [
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
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fhir:text [ fhir:v "FEvIR Linking Identifier" ]             ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-4" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]             ]           ] ;
fhir:display [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]         ] )       ] )     ] [
fhir:title [ fhir:v "3.3 Exploratory Objective(s)" ] ;
fhir:code [
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218531" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 3.3 Exploratory Objective(s)" ]         ] ) ;
fhir:text [ fhir:v "3.3-Exploratory-Objective(s)" ]       ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>"^^rdf:XMLLiteral ]       ] ;
      ( fhir:section [
fhir:title [ fhir:v "3.3.1 Exploratory Objective 1" ] ;
fhir:code [
          ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218532" ] ;
fhir:display [ fhir:v "ICH M11 Protocol Section 3.3.1 Exploratory Objective" ]           ] )         ] ;
fhir:focus [
fhir:display [ fhir:v "Presence of anti-glucagon antibodies" ]         ] ;
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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><div><p>   </p>\n</div>\n<div><strong>Exploratory Objectives</strong>\n    <p><strong>Description </strong>Explore the formation of anti-glucagon antibodies to glucagon</p>\n    <p><strong>Outcome Measures:</strong></p>\n    <p><strong>Unnamed outcome measure</strong></p>\n    <table>\n        <tbody>\n            <tr>\n                <td><strong>Endpoint</strong></td>\n                <td>Presence of anti-glucagon antibodies</td>\n            </tr>\n        </tbody>\n    </table><p>      </p>\n    <p><strong>Name: </strong>To evaluate the recovery from clinical symptoms of hypoglycemia</p>\n    <p><strong>Description </strong>Hypoglycemia symptoms questionnaire</p></div></div>"^^rdf:XMLLiteral ]         ] ;
        ( fhir:entry [
fhir:display [ fhir:v "Presence of anti-glucagon antibodies" ]         ] )       ] )     ] )
  ] ) . #