A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus - TTL Representation - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2

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
: A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus - 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 sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "399864"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "5" ] ;
fhir:lastUpdated [ fhir:v "2025-09-14T18:44:20.424Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile>     ] [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-design"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/study-design>     ] [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-registry-record"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/study-registry-record>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy IGBJ-ResearchStudy</b></p><p><a name=\"IGBJ-ResearchStudy\"> </a><a name=\"hcIGBJ-ResearchStudy\"> </a></p><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-profile.html\">M11 Research Study</a></p></div><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-1.3.html\">Composition IGBJ Protocol Narrative 1.3</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-2.1.html\">Composition IGBJ Protocol Narrative 2.1</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-5.1.html\">Composition IGBJ Protocol Narrative 5.1</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-9.html\">Composition IGBJ Protocol Narrative 9</a></p><blockquote><p><b>M11_ProtocolAmendment</b></p><blockquote><p><b>url</b></p>scope</blockquote><p><b>value</b>: C217026</p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/valueset-country.html\">Country ValueSet</a></blockquote><p><b>value</b>: DE</p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/valueset-country.html\">Country ValueSet</a></blockquote><p><b>value</b>: GB</p><blockquote><p><b>url</b></p>region</blockquote><p><b>value</b>: AU-NSW</p><blockquote><p><b>url</b></p>site</blockquote><p><b>value</b>: <code>https://example.org/site-identifier</code>/sss</p><blockquote><p><b>url</b></p>approvalDate</blockquote><p><b>value</b>: 2017-12-05</p><blockquote><p><b>url</b></p>signature</blockquote><p><b>value</b>: No display for Signature  (data: 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)</p><blockquote><p><b>url</b></p>signatureURL</blockquote><p><b>value</b>: https://somelocation</p><blockquote><p><b>url</b></p>signatureMethod</blockquote><p><b>value</b>: electronic and wet ink copy</p><p><b>scope</b>: C41065</p><p><b>number</b>: 234</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-ResearchStudyStudyAmendmentScopeImpact.html\">ResearchStudyStudyAmendmentScopeImpact</a></blockquote><p><b>scope</b>: C68846</p><p><b>number</b>: 983</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-ResearchStudyStudyAmendmentScopeImpact.html\">ResearchStudyStudyAmendmentScopeImpact</a></blockquote><blockquote><p><b>url</b></p>primaryReason</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218490}\">Regulatory Agency Request To Amend</span></p><blockquote><p><b>url</b></p>secondaryReason</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218494}\">Manufacturing Change</span></p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/codesystem-example-summary.html\">summary</a></blockquote><p><b>value</b>: Regulator required manufacturing chanage.</p><blockquote><p><b>url</b></p>substantialImpactSafety</blockquote><p><b>value</b>: C49488</p><blockquote><p><b>url</b></p>substantialImpactSafetyComment</blockquote><p><b>value</b>: Specifically implemented to decrease safety risks.</p><blockquote><p><b>url</b></p>substantialImpactReliability</blockquote><p><b>value</b>: C17998</p><blockquote><p><b>url</b></p>substantialImpactReliabilityComment</blockquote><p><b>value</b>: ccc</p><p><b>detail</b>: amendment one</p><p><b>rationale</b>: clarification</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218515}\">1.1 Protocol Synopsis</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-protocol-amendment-detail.html\">ResearchStudyStudyAmendmentDetails</a></blockquote><p><b>detail</b>: amendment two</p><p><b>rationale</b>: exclude regular drinkers</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218550}\">5.3 Exclusion Criteria</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-protocol-amendment-detail.html\">ResearchStudyStudyAmendmentDetails</a></blockquote><blockquote><p><b>url</b></p>rationale</blockquote><p><b>value</b>: Updates to address safety concern &amp; align with product guidelines.</p><blockquote><p><b>url</b></p>description</blockquote><p><b>value</b>: Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus has been amended. The new protocol is indicated by Amendment (a) and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: • An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. • The GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015).</p></blockquote><p><b>ResearchStudySponsorConfidentialityStatement</b>: All data is confidential</p><p><b>identifier</b>: Regulatory Agency Identifier/NCT03421379 (use: official, ), Sponsor Identifier/I8R-JE-IGBJ (use: usual, ), Amendment Identifier/I8R-JE-IGBJ(a) (use: usual, )</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus</p><h3>Labels</h3><table class=\"grid\"><tbody><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/title-type short-title}\">Short title</span></td><td>A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus</td></tr></tbody></table><p><b>date</b>: 2017-12-05</p><p><b>status</b>: Draft</p><p><b>phase</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}\">Phase 3</span></p><h3>Focus</h3><table class=\"grid\"><tbody><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicinalProductDefinition-IGBJ-MedicinalProduct.html\">MedicinalProductDefinition: identifier = Sponsor Investigational Product Code: LY900018</a></td></tr></tbody></table><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p></div>"^^rdf:XMLLiteral
  ] ; # 
  fhir:contained ( [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT03421379-drug------glucagon-nasal-powder" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition>       ] )     ] ;
fhir:name [ fhir:v "NCT03421379_drug______glucagon_nasal_powder" ] ;
fhir:title [ fhir:v "Glucagon Nasal Powder" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Administered intranasally" ] ;
    ( fhir:note [
fhir:text [ fhir:v "suggested alternative name: LY900018" ]     ] ) ;
fhir:handling [ fhir:v "boolean" ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "Intervention Type: DRUG" ]     ] )
  ] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT03421379-drug------glucagon-hydrochloride-solution" ] ;
fhir:meta [
      ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition>       ] )     ] ;
fhir:name [ fhir:v "NCT03421379_drug______glucagon_hydrochloride_solution" ] ;
fhir:title [ fhir:v "Glucagon Hydrochloride Solution" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "Administered IM" ] ;
    ( fhir:note [
fhir:text [ fhir:v "suggested alternative name: GlucaGen®" ]     ] ) ;
fhir:handling [ fhir:v "boolean" ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "Intervention Type: DRUG" ]     ] )
  ] [
a fhir:Group ;
fhir:id [ fhir:v "NCT03421379-comparison-group-0" ] ;
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Computable Publishing®: [System]-to-FEvIR Converter" ]       ]     ] ) ;
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fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]       ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-comparison-group-0" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]       ]     ] ) ;
fhir:title [ fhir:v "NCT03421379 Comparison Group: Glucagon Nasal Powder" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally." ] ;
fhir:membership [ fhir:v "conceptual" ] ;
fhir:code [
fhir:text [ fhir:v "Experimental" ]     ] ;
    ( fhir:characteristic [
fhir:code [
fhir:text [ fhir:v "Exposed to" ]       ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "#NCT03421379-drug------glucagon-nasal-powder" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Glucagon Nasal Powder" ]       ] ;
fhir:exclude [ fhir:v false ]     ] )
  ] [
a fhir:Group ;
fhir:id [ fhir:v "NCT03421379-comparison-group-1" ] ;
    ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
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fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]       ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-comparison-group-1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]       ]     ] ) ;
fhir:title [ fhir:v "NCT03421379 Comparison Group: Glucagon Hydrochloride Solution" ] ;
fhir:status [ fhir:v "active" ] ;
fhir:description [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)" ] ;
fhir:membership [ fhir:v "conceptual" ] ;
fhir:code [
fhir:text [ fhir:v "Active Comparator" ]     ] ;
    ( fhir:characteristic [
fhir:code [
fhir:text [ fhir:v "Exposed to" ]       ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "#NCT03421379-drug------glucagon-hydrochloride-solution" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Drug: Glucagon Hydrochloride Solution" ]       ] ;
fhir:exclude [ fhir:v false ]     ] )
  ] [
a fhir:Location ;
fhir:id [ fhir:v "NCT03421379-Location-0" ] ;
fhir:name [ fhir:v "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician." ] ;
fhir:address [
fhir:city [ fhir:v "Fukuoka" ] ;
fhir:postalCode [ fhir:v "812-0025" ] ;
fhir:country [ fhir:v "Japan" ]     ] ;
fhir:position [
fhir:longitude [ fhir:v 130.41667 ] ;
fhir:latitude [ fhir:v 33.6 ]     ]
  ] [
a fhir:Location ;
fhir:id [ fhir:v "NCT03421379-Location-1" ] ;
fhir:name [ fhir:v "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician." ] ;
fhir:address [
fhir:city [ fhir:v "Tokyo" ] ;
fhir:postalCode [ fhir:v "130-0004" ] ;
fhir:country [ fhir:v "Japan" ]     ] ;
fhir:position [
fhir:longitude [ fhir:v 139.69171 ] ;
fhir:latitude [ fhir:v 35.6895 ]     ]
  ] [
a fhir:Location ;
fhir:id [ fhir:v "NCT03421379-Location-2" ] ;
fhir:name [ fhir:v "For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician." ] ;
fhir:address [
fhir:city [ fhir:v "Tokyo" ] ;
fhir:postalCode [ fhir:v "162-0053" ] ;
fhir:country [ fhir:v "Japan" ]     ] ;
fhir:position [
fhir:longitude [ fhir:v 139.69171 ] ;
fhir:latitude [ fhir:v 35.6895 ]     ]
  ] [
a fhir:Location ;
fhir:id [ fhir:v "NCT03421379-Location-3" ] ;
fhir:name [ fhir:v "For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician." ] ;
fhir:address [
fhir:city [ fhir:v "Tokyo" ] ;
fhir:postalCode [ fhir:v "169-0073" ] ;
fhir:country [ fhir:v "Japan" ]     ] ;
fhir:position [
fhir:longitude [ fhir:v 139.69171 ] ;
fhir:latitude [ fhir:v 35.6895 ]     ]
  ] ) ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Composition/399865" ] ;
fhir:type [ fhir:v "Composition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "IGBJ Protocol Narrative 1.3" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Composition/399866" ] ;
fhir:type [ fhir:v "Composition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "IGBJ Protocol Narrative 2.1" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Composition/399867" ] ;
fhir:type [ fhir:v "Composition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "IGBJ Protocol Narrative 5.1" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Composition/399868" ] ;
fhir:type [ fhir:v "Composition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "IGBJ Protocol Narrative 9" ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "scope"^^xsd:anyURI ] ;
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a fhir:code ;
fhir:v "C217026"       ]     ] [
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fhir:value [
a fhir:code ;
fhir:v "DE"       ]     ] [
fhir:url [ fhir:v "country"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "GB"       ]     ] [
fhir:url [ fhir:v "region"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "AU-NSW"       ]     ] [
fhir:url [ fhir:v "site"^^xsd:anyURI ] ;
fhir:value [
a fhir:Identifier ;
fhir:system [ fhir:v "https://example.org/site-identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "sss" ]       ]     ] [
fhir:url [ fhir:v "approvalDate"^^xsd:anyURI ] ;
fhir:value [
a fhir:date ;
fhir:v "2017-12-05"^^xsd:date       ]     ] [
fhir:url [ fhir:v "signature"^^xsd:anyURI ] ;
fhir:value [
a fhir:Signature ;
fhir:data [ fhir:v "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"^^xsd:base64Binary ]       ]     ] [
fhir:url [ fhir:v "signatureURL"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "https://somelocation"       ]     ] [
fhir:url [ fhir:v "signatureMethod"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "electronic and wet ink copy"       ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "scope"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "C41065"         ]       ] [
fhir:url [ fhir:v "number"^^xsd:anyURI ] ;
fhir:value [
a fhir:positiveInt ;
fhir:v "234"^^xsd:positiveInteger         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "scope"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "C68846"         ]       ] [
fhir:url [ fhir:v "number"^^xsd:anyURI ] ;
fhir:value [
a fhir:positiveInt ;
fhir:v "983"^^xsd:positiveInteger         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "primaryReason"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218490" ] ;
fhir:display [ fhir:v "Regulatory Agency Request To Amend" ]         ] )       ]     ] [
fhir:url [ fhir:v "secondaryReason"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218494" ] ;
fhir:display [ fhir:v "Manufacturing Change" ]         ] )       ]     ] [
fhir:url [ fhir:v "summary"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Regulator required manufacturing chanage."       ]     ] [
fhir:url [ fhir:v "substantialImpactSafety"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "C49488"       ]     ] [
fhir:url [ fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Specifically implemented to decrease safety risks."       ]     ] [
fhir:url [ fhir:v "substantialImpactReliability"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "C17998"       ]     ] [
fhir:url [ fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "ccc"       ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "detail"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "amendment one"         ]       ] [
fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "clarification"         ]       ] [
fhir:url [ fhir:v "section"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218515" ] ;
fhir:display [ fhir:v "1.1 Protocol Synopsis" ]           ] )         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "detail"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "amendment two"         ]       ] [
fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "exclude regular drinkers"         ]       ] [
fhir:url [ fhir:v "section"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C218550" ] ;
fhir:display [ fhir:v "5.3 Exclusion Criteria" ]           ] )         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Updates to address safety concern & align with product guidelines."       ]     ] [
fhir:url [ fhir:v "description"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus has been amended. The new protocol is indicated by Amendment (a) and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: • An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. • The GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015)."       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Brian S. Alper, MD, MSPH" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "All data is confidential"     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "registration-submission" ] ;
fhir:display [ fhir:v "Registration submission" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2018-01-30"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "results-submission" ] ;
fhir:display [ fhir:v "Results submission" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2019-08-14"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "registration-submission-qc" ] ;
fhir:display [ fhir:v "Registration submission Quality Check" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2018-01-30"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "results-submission-qc" ] ;
fhir:display [ fhir:v "Results submission Quality Check" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2019-09-18"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "record-verification" ] ;
fhir:display [ fhir:v "Record Verification" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:end [ fhir:v "2019-09"^^xsd:gYearMonth ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "update-submission" ] ;
fhir:display [ fhir:v "Update submission" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:end [ fhir:v "2019-09-18"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "registration-posting" ] ;
fhir:display [ fhir:v "Registration posting" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2018-02-05"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "results-posting" ] ;
fhir:display [ fhir:v "Results posting" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:start [ fhir:v "2019-10-08"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary-outcome-data-collection" ] ;
fhir:display [ fhir:v "Primary outcome data collection" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:end [ fhir:v "2018-08-20"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-registration-activity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "update-posting" ] ;
fhir:display [ fhir:v "Update posting" ]         ] )       ]     ] [
fhir:url [ fhir:v "actual"^^xsd:anyURI ] ;
fhir:value [
a fhir:boolean ;
fhir:v true       ]     ] [
fhir:url [ fhir:v "period"^^xsd:anyURI ] ;
fhir:value [
a fhir:Period ;
fhir:end [ fhir:v "2019-10-08"^^xsd:date ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-author"^^xsd:anyURI ] ;
fhir:value [
a fhir:ContactDetail ;
fhir:name [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ]     ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/ResearchStudy/399864"^^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 "399864" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] [
fhir:use [ fhir:v "official" ] ;
fhir:type [
fhir:text [ fhir:v "Regulatory Agency Identifier" ]     ] ;
fhir:system [ fhir:v "https://example.org/regulatory-agency-identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379" ]
  ] [
fhir:use [ fhir:v "usual" ] ;
fhir:type [
fhir:text [ fhir:v "Sponsor Identifier" ]     ] ;
fhir:system [ fhir:v "https://example.org/sponsor-identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "I8R-JE-IGBJ" ]
  ] [
fhir:use [ fhir:v "usual" ] ;
fhir:type [
fhir:text [ fhir:v "Amendment Identifier" ]     ] ;
fhir:system [ fhir:v "https://example.org/amendment-identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "I8R-JE-IGBJ(a)" ]
  ] [
fhir:use [ fhir:v "official" ] ;
fhir:system [ fhir:v "https://clinicaltrials.gov"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379" ]
  ] [
fhir:value [ fhir:v "16962" ] ;
fhir:assigner [
fhir:display [ fhir:v "Eli Lilly and Company" ]     ]
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-SecondaryIdType"^^xsd:anyURI ] ;
fhir:code [ fhir:v "OTHER" ] ;
fhir:display [ fhir:v "Other Identifier" ]       ] )     ] ;
fhir:value [ fhir:v "I8R-JE-IGBJ" ] ;
fhir:assigner [
fhir:display [ fhir:v "Eli Lilly and Company" ]     ]
  ] ) ; # 
  fhir:version [ fhir:v "(a)"] ; # 
  fhir:title [ 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"] ; # 
  fhir:label ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "short-title" ] ;
fhir:display [ fhir:v "Short title" ]       ] )     ] ;
fhir:value [ fhir:v "Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus" ]
  ] ) ; # 
  fhir:citeAs [ 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 [Database Entry: FHIR ResearchStudy Resource]. Contributors: Brian S. Alper, MD, MSPH, Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399864. Revised 2017-12-05. Available at: https://fevir.net/resources/ResearchStudy/399864. Computable resource at: https://fevir.net/resources/ResearchStudy/399864#json."] ; # 
  fhir:relatesTo ( [
fhir:type [ fhir:v "cites" ] ;
fhir:target [
a fhir:Reference ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:identifier [
fhir:system [ fhir:v "https://pubmed.ncbi.nlm.nih.gov"^^xsd:anyURI ] ;
fhir:value [ fhir:v "38444629" ]       ] ;
fhir:display [ fhir:v "Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19." ]     ]
  ] [
fhir:type [ fhir:v "supported-with" ] ;
fhir:target [
a fhir:Attachment ;
fhir:url [ fhir:v "https://www.clinicalstudydatarequest.com"^^xsd:anyURI ] ;
fhir:title [ fhir:v "IPD Sharing URL" ]     ]
  ] [
fhir:type [ fhir:v "documentation" ] ;
fhir:target [
a fhir:Attachment ;
fhir:contentType [ fhir:v "application/pdf" ] ;
fhir:url [ fhir:v "https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/Prot_000.pdf"^^xsd:anyURI ] ;
fhir:size [ fhir:v "684592"^^xsd:long ] ;
fhir:title [ fhir:v "ProtStudy Protocol" ] ;
fhir:creation [ fhir:v "2017-12-05"^^xsd:date ]     ]
  ] [
fhir:type [ fhir:v "documentation" ] ;
fhir:target [
a fhir:Attachment ;
fhir:contentType [ fhir:v "application/pdf" ] ;
fhir:url [ fhir:v "https://cdn.clinicaltrials.gov/large-docs/79/NCT03421379/SAP_001.pdf"^^xsd:anyURI ] ;
fhir:size [ fhir:v "444216"^^xsd:long ] ;
fhir:title [ fhir:v "SAPStatistical Analysis Plan" ] ;
fhir:creation [ fhir:v "2018-02-02"^^xsd:date ]     ]
  ] ) ; # 
  fhir:date [ fhir:v "2017-12-05"^^xsd:date] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:primaryPurposeType [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "treatment" ] ;
fhir:display [ fhir:v "Treatment" ]     ] )
  ] ; # 
  fhir:phase [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C15602" ] ;
fhir:display [ fhir:v "Phase 3" ]     ] [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI ] ;
fhir:code [ fhir:v "phase-3" ] ;
fhir:display [ fhir:v "Phase 3" ]     ] )
  ] ; # 
  fhir:studyDesign ( [
fhir:text [ fhir:v "Design Masking: None (Open Label)" ]
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/sevco"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01003" ] ;
fhir:display [ fhir:v "randomized assignment" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/sevco"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01012" ] ;
fhir:display [ fhir:v "Crossover cohort design" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "https://fevir.net/sevco"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01001" ] ;
fhir:display [ fhir:v "interventional research" ]     ] )
  ] ) ; # 
  fhir:focus ( [
fhir:reference [
fhir:reference [ fhir:v "MedicinalProductDefinition/399870" ] ;
fhir:type [ fhir:v "MedicinalProductDefinition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "MedicinalProductDefinition submitted as Resource 7 of 7 (399870)" ]     ]
  ] ) ; # 
  fhir:condition ( [
    ( fhir:coding [
a sct:1137328006 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "1137328006" ] ;
fhir:display [ fhir:v "Iatrogenic hypoglycaemia" ]     ] )
  ] [
fhir:text [ fhir:v "Diabetes Mellitus" ]
  ] ) ; # 
  fhir:descriptionSummary [ fhir:v "The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus."] ; # 
  fhir:site ( [
fhir:reference [ fhir:v "#NCT03421379-Location-0" ] ;
fhir:type [ fhir:v "Location"^^xsd:anyURI ]
  ] [
fhir:reference [ fhir:v "#NCT03421379-Location-1" ] ;
fhir:type [ fhir:v "Location"^^xsd:anyURI ]
  ] [
fhir:reference [ fhir:v "#NCT03421379-Location-2" ] ;
fhir:type [ fhir:v "Location"^^xsd:anyURI ]
  ] [
fhir:reference [ fhir:v "#NCT03421379-Location-3" ] ;
fhir:type [ fhir:v "Location"^^xsd:anyURI ]
  ] ) ; # 
  fhir:classifier ( [
fhir:text [ fhir:v "IPDSharing: Yes" ]
  ] [
fhir:text [ fhir:v "IPDSharingDescription: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement." ]
  ] [
fhir:text [ fhir:v "IPDSharingInfoType: Study Protocol" ]
  ] [
fhir:text [ fhir:v "IPDSharingInfoType: Statistical Analysis Plan (SAP)" ]
  ] [
fhir:text [ fhir:v "IPDSharingInfoType: Clinical Study Report (CSR)" ]
  ] [
fhir:text [ fhir:v "IPDSharingTimeFrame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting." ]
  ] [
fhir:text [ fhir:v "IPDSharingAccessCriteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement." ]
  ] [
fhir:text [ fhir:v "Has Results: True" ]
  ] [
fhir:text [ fhir:v "Oversight Classifier: oversightHasDmc False" ]
  ] [
fhir:text [ fhir:v "Oversight Classifier: isFdaRegulatedDrug True" ]
  ] [
fhir:text [ fhir:v "Oversight Classifier: isFdaRegulatedDevice False" ]
  ] [
fhir:text [ fhir:v "Oversight Classifier: isUsExport True" ]
  ] [
fhir:text [ fhir:v "AgreementPISponsorEmployee: False" ]
  ] [
fhir:text [ fhir:v "AgreementRestrictionType: GT60" ]
  ] [
fhir:text [ fhir:v "AgreementRestrictiveAgreement: True" ]
  ] ) ; # 
  fhir:associatedParty ( [
fhir:name [ fhir:v "Eli Lilly and Company" ] ;
fhir:role [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "sponsor" ] ;
fhir:display [ fhir:v "Sponsor" ]       ] )     ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "INDUSTRY" ]     ] )
  ] [
fhir:name [ fhir:v "Eli Lilly and Company" ] ;
fhir:role [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "lead-sponsor" ] ;
fhir:display [ fhir:v "Lead sponsor" ]       ] )     ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "INDUSTRY" ]     ] )
  ] [
fhir:name [ fhir:v "Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)" ] ;
fhir:role [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-party-role"^^xsd:anyURI ] ;
fhir:code [ fhir:v "study-chair" ] ;
fhir:display [ fhir:v "Study chair" ]       ] )     ] ;
fhir:party [
fhir:display [ fhir:v "Eli Lilly and Company" ]     ]
  ] ) ; # 
  fhir:progressStatus ( [
fhir:state [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "completed" ] ;
fhir:display [ fhir:v "Completed" ]       ] )     ]
  ] [
fhir:state [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "overall-study" ] ;
fhir:display [ fhir:v "Overall study" ]       ] )     ] ;
fhir:actual [ fhir:v true ] ;
fhir:period [
fhir:start [ fhir:v "2018-02-21"^^xsd:date ] ;
fhir:end [ fhir:v "2018-08-20"^^xsd:date ]     ]
  ] ) ; # 
  fhir:recruitment [
fhir:actualNumber [ fhir:v "75"^^xsd:nonNegativeInteger ] ;
fhir:eligibility [
fhir:reference [ fhir:v "Group/267225" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]         ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379 Eligibility Criteria" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]         ]       ] ;
fhir:display [ fhir:v "NCT03421379 Eligibility Criteria" ]     ]
  ] ; # 
  fhir:comparisonGroup ( [
fhir:eligibility [
fhir:reference [ fhir:v "#NCT03421379-comparison-group-0" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Glucagon Nasal Powder: A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally." ]     ]
  ] [
fhir:eligibility [
fhir:reference [ fhir:v "#NCT03421379-comparison-group-1" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Glucagon Hydrochloride Solution: A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)" ]     ]
  ] ) ; # 
  fhir:objective ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]       ] )     ] ;
    ( fhir:outcomeMeasure [
fhir:name [ fhir:v "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]         ] )       ] ;
fhir:description [ fhir:v "Percentage of participants who achieved treatment success during the controlled insulin-induced hypoglycemia in participants with type 1 diabetes mellitus (T1DM) and participants with type 2 diabetes mellitus (T2DM).Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267226" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]           ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-primaryOutcome-0" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]           ]         ]       ]     ] )
  ] [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ] ;
    ( fhir:outcomeMeasure [
fhir:name [ fhir:v "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]         ] )       ] ;
fhir:description [ fhir:v "PD assessment measured the change from Baseline in maximal blood glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride intramuscular (IM)." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267227" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]           ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-0" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]           ]         ]       ]     ] [
fhir:name [ fhir:v "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]         ] )       ] ;
fhir:description [ fhir:v "PD assessment measured the time to maximal concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267228" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]           ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-1" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]           ]         ]       ]     ] [
fhir:name [ fhir:v "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" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]         ] )       ] ;
fhir:description [ fhir:v "PK assessment measured the change from baseline in the area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of Glucagon Nasal Powder and Glucagon Hydrochloride IM." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267229" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]           ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-2" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]           ]         ]       ]     ] [
fhir:name [ fhir:v "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]         ] )       ] ;
fhir:description [ fhir:v "PK assessment measured the change from baseline in maximal concentration (Cmax) of glucagon nasal powder and glucagon hydrochloride IM." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267230" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]           ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379-secondaryOutcome-3" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]           ]         ]       ]     ] [
fhir:name [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ] ;
fhir:type [
        ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]         ] )       ] ;
fhir:description [ fhir:v "PK assessment measured the change from baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM." ] ;
fhir:endpoint [
fhir:reference [ fhir:v "EvidenceVariable/267231" ] ;
fhir:type [ fhir:v "EvidenceVariable"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
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:result ( [
fhir:reference [ fhir:v "Composition/267224" ] ;
fhir:type [ fhir:v "Composition"^^xsd:anyURI ] ;
fhir:identifier [
fhir:type [
fhir:text [ fhir:v "FEvIR Linking Identifier" ]       ] ;
fhir:system [ fhir:v "https://fevir.net/FLI"^^xsd:anyURI ] ;
fhir:value [ fhir:v "NCT03421379 Results Report" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]       ]     ] ;
fhir:display [ fhir:v "Results Section for NCT03421379" ]
  ] ) . #