@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 -------------------------------------------------------------------

<http://hl7.org/fhir/uv/ebm/Composition/568060> a fhir:Composition ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "568060"] ; # 
  fhir:meta [
     fhir:versionId [ fhir:v "5" ] ;
     fhir:lastUpdated [ fhir:v "2026-06-22T14:51:09.037Z"^^xsd:dateTime ] ;
     fhir:profile ( [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-03"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report-section-03>
     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
     fhir:status [ fhir:v "additional" ] ;
     fhir:div [ fhir:v "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\"/>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
     fhir:url [
       fhir:v "http://hl7.org/fhir/StructureDefinition/artifact-description"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/StructureDefinition/artifact-description>
     ] ;
     fhir:value [
       a fhir:Markdown ;
       fhir:v "Example of M11ReportSection03 Profile"
     ]
  ] [
     fhir:url [
       fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status"^^xsd:anyURI ;
       fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status>
     ] ;
     fhir:value [
       a fhir:CodeableConcept ;
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/cited-artifact-status-type>
         ] ;
         fhir:code [ fhir:v "active" ] ;
         fhir:display [ fhir:v "Active" ]
       ] )
     ]
  ] ) ; # 
  fhir:url [
     fhir:v "https://fevir.net/resources/Composition/568060"^^xsd:anyURI ;
     fhir:l <https://fevir.net/resources/Composition/568060>
  ] ; # 
  fhir:identifier ( [
     fhir:type [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://terminology.hl7.org/CodeSystem/v2-0203"^^xsd:anyURI ;
           fhir:l <http://terminology.hl7.org/CodeSystem/v2-0203>
         ] ;
         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:l <https://fevir.net/FOI>
     ] ;
     fhir:value [ fhir:v "568060" ] ;
     fhir:assigner [
       fhir:display [ fhir:v "Computable Publishing LLC" ]
     ]
  ] ) ; # 
  fhir:status [ fhir:v "final"] ; # 
  fhir:type [
     fhir:coding ( [
       a loinc:35528-9 ;
       fhir:system [
         fhir:v "http://loinc.org"^^xsd:anyURI ;
         fhir:l <http://loinc.org>
       ] ;
       fhir:code [ fhir:v "35528-9" ] ;
       fhir:display [ fhir:v "Clinical trial protocol Clinical trial protocol" ]
     ] ) ;
     fhir:text [ fhir:v "CeSHarP Report" ]
  ] ; # 
  fhir:category ( [
     fhir:coding ( [
       fhir:system [
         fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
         fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
       ] ;
       fhir:code [ fhir:v "C218526" ] ;
       fhir:display [ fhir:v "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS" ]
     ] ) ;
     fhir:text [ fhir:v "section3-estimands" ]
  ] ) ; # 
  fhir:subject ( [
     fhir:l <http://hl7.org/fhir/uv/ebm/ResearchStudy/267245> ;
     fhir:reference [ fhir:v "ResearchStudy/267245" ] ;
     fhir:type [
       fhir:v "ResearchStudy"^^xsd:anyURI ;
       fhir:l fhir:ResearchStudy
     ] ;
     fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]
  ] ) ; # 
  fhir:date [ fhir:v "2026-06-22T14:51:09.037Z"^^xsd:dateTime] ; # 
  fhir:author ( [
     fhir:display [ fhir:v "Brian S. Alper, MD, MSPH" ]
  ] ) ; # 
  fhir:title [ fhir:v "M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"] ; # 
  fhir:custodian [
     fhir:l <http://hl7.org/fhir/uv/ebm/Organization/118079> ;
     fhir:reference [ fhir:v "Organization/118079" ] ;
     fhir:type [
       fhir:v "Organization"^^xsd:anyURI ;
       fhir:l fhir:Organization
     ] ;
     fhir:display [ fhir:v "Computable Publishing LLC" ]
  ] ; # 
  fhir:relatesTo ( [
     fhir:type [ fhir:v "derived-from" ] ;
     fhir:target [
       a fhir:Reference ;
       fhir:l <http://hl7.org/fhir/uv/ebm/ResearchStudy/267245> ;
       fhir:reference [ fhir:v "ResearchStudy/267245" ] ;
       fhir:type [
         fhir:v "ResearchStudy"^^xsd:anyURI ;
         fhir:l fhir:ResearchStudy
       ] ;
       fhir:display [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example" ]
     ]
  ] [
     fhir:type [ fhir:v "cite-as" ] ;
     fhir:target [
       a fhir:Markdown ;
       fhir:v "M11 Report Section 3 (Trial Objectives and Associated Estimands) for A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568060. Revised 2026-06-22. Available at: https://fevir.net/resources/Composition/568060. Computable resource at: https://fevir.net/resources/Composition/568060#json."
     ]
  ] ) ; # 
  fhir:section ( [
     fhir:title [ fhir:v "3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS" ] ;
     fhir:code [
       fhir:coding ( [
         fhir:system [
           fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
           fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
         ] ;
         fhir:code [ fhir:v "C218526" ] ;
         fhir:display [ fhir:v "ICH M11 Protocol Section 3 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS" ]
       ] ) ;
       fhir:text [ fhir:v "section3-estimands" ]
     ] ;
     fhir:text [
       fhir:status [ fhir:v "empty" ] ;
       fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"^^rdf:XMLLiteral ]
     ] ;
     fhir:section ( [
       fhir:title [ fhir:v "3.1 Primary Objective(s) and Associated Estimand(s)" ] ;
       fhir:code [
         fhir:coding ( [
           fhir:system [
             fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
             fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
           ] ;
           fhir:code [ fhir:v "C218527" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 3.1 Primary Objective(s) and Associated Estimand(s)" ]
         ] ) ;
         fhir:text [ fhir:v "3.1-Primary-Objective(s)-and-Associated-Estimand(s)" ]
       ] ;
       fhir:text [
         fhir:status [ fhir:v "empty" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"^^rdf:XMLLiteral ]
       ] ;
       fhir:section ( [
         fhir:title [ fhir:v "3.1.1 Primary Objective 1" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218528" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.1.1 Primary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-primaryOutcome-0" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "additional" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Primary objective label: Treatment success</p><p>Primary objective description:To demonstrate that 3 mg LY900018 is non-inferior to 1 mg IMG for the proportion of patients achieving treatment success from insulin-induced hypoglycemia using a non-inferiority margin of 10%</p><table><tbody><tr><th>Type</th><th>Primary</th></tr><tr><td>Population</td><td>Study Population.</td></tr><tr><td>Treatment</td><td>Glucagon Nasal Powder (Experimental)</td></tr><tr><td>Treatment</td><td>Glucagon Hydrochloride Solution (Active Comparator)</td></tr><tr><td>Endpoint</td><td><p>Proportion achieving treatment success</p><p>Endpoint title: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)</p><p>Outcome description: The proportion of patients achieving treatment success defined as either an increase in PG to &gt;70 mg/dL or an increase of &gt;20 mg/dL from nadir within 30 minutes after administration of glucagon. The nadir is defined as the minimum PG value at the time of or within 10 minutes following glucagon administration.</p></td></tr><tr><td>Population-level Summary</td><td>risk difference</td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
         ] ;
         fhir:entry ( [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-primaryOutcome-0" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia (NCT03421379)" ]
         ] [
           fhir:l <http://hl7.org/fhir/uv/ebm/Group/267506> ;
           fhir:reference [ fhir:v "Group/267506" ] ;
           fhir:type [
             fhir:v "Group"^^xsd:anyURI ;
             fhir:l fhir:Group
           ] ;
           fhir:display [ fhir:v "M11 IGBJ Protocol Example Eligibility Criteria" ]
         ] [
           fhir:l <http://hl7.org/fhir/uv/ebm/Group/370701> ;
           fhir:reference [ fhir:v "Group/370701" ] ;
           fhir:type [
             fhir:v "Group"^^xsd:anyURI ;
             fhir:l fhir:Group
           ] ;
           fhir:display [ fhir:v "Glucagon Nasal Powder (Experimental)" ]
         ] [
           fhir:l <http://hl7.org/fhir/uv/ebm/Group/370702> ;
           fhir:reference [ fhir:v "Group/370702" ] ;
           fhir:type [
             fhir:v "Group"^^xsd:anyURI ;
             fhir:l fhir:Group
           ] ;
           fhir:display [ fhir:v "Glucagon Hydrochloride Solution (Active Comparator)" ]
         ] )
       ] )
     ] [
       fhir:title [ fhir:v "3.2 Secondary Objective(s) and Associated Estimand(s)" ] ;
       fhir:code [
         fhir:coding ( [
           fhir:system [
             fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
             fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
           ] ;
           fhir:code [ fhir:v "C218529" ] ;
           fhir:display [ fhir:v "ICH M11 Protocol Section 3.2 Secondary Objective(s) and Associated Estimand(s)" ]
         ] ) ;
         fhir:text [ fhir:v "3.2-Secondary-Objective(s)-and-Associated-Estimand(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 "3.2.1 Secondary Objective 1" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:display [ fhir:v "serious adverse events (SAEs)" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "additional" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: Safety and tolerability</p><p>Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>serious adverse events (SAEs)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
         ] ;
         fhir:entry ( [
           fhir:display [ fhir:v "serious adverse events (SAEs)" ]
         ] )
       ] [
         fhir:title [ fhir:v "3.2.1 Secondary Objective 2" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:display [ fhir:v "treatment-emergent adverse events (TEAEs)" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "additional" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Secondary objective label: Safety and tolerability</p><p>Secondary objective description: To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG</p><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>treatment-emergent adverse events (TEAEs)</p><p>Outcome description: treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
         ] ;
         fhir:entry ( [
           fhir:display [ fhir:v "treatment-emergent adverse events (TEAEs)" ]
         ] )
       ] [
         fhir:title [ fhir:v "3.2.1 Secondary Objective 3" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:display [ fhir:v "vital signs" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "generated" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>vital signs</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
         ] ;
         fhir:entry ( [
           fhir:display [ fhir:v "vital signs" ]
         ] )
       ] [
         fhir:title [ fhir:v "3.2.1 Secondary Objective 4" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-0" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (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>Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
         ] ;
         fhir:entry ( [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-0" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) (NCT03421379)" ]
         ] )
       ] [
         fhir:title [ fhir:v "3.2.1 Secondary Objective 5" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-1" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "generated" ] ;
           fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><table><tbody><tr><th>Estimand Characteristic</th><th>Description</th></tr><tr><td>Endpoint</td><td><p>PD: Time to Maximal Concentration (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 ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
             fhir:system [
               fhir:v "https://fevir.net/FLI"^^xsd:anyURI ;
               fhir:l <https://fevir.net/FLI>
             ] ;
             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-1" ] ;
             fhir:assigner [
               fhir:display [ fhir:v "Computable Publishing LLC" ]
             ]
           ] ;
           fhir:display [ fhir:v "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]
         ] )
       ] [
         fhir:title [ fhir:v "3.2.1 Secondary Objective 6" ] ;
         fhir:code [
           fhir:coding ( [
             fhir:system [
               fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ;
               fhir:l <http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl>
             ] ;
             fhir:code [ fhir:v "C218530" ] ;
             fhir:display [ fhir:v "ICH M11 Protocol Section 3.2.1 Secondary Objective" ]
           ] )
         ] ;
         fhir:focus [
           fhir:type [
             fhir:v "EvidenceVariable"^^xsd:anyURI ;
             fhir:l fhir:EvidenceVariable
           ] ;
           fhir:identifier [
             fhir:type [
               fhir:text [ fhir:v "FEvIR Linking Identifier" ]
             ] ;
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         ] ;
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           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>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 (NCT03421379)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
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         ] )
       ] [
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             fhir:code [ fhir:v "C218530" ] ;
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             ] ;
             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-3" ] ;
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           ] ;
           fhir:display [ fhir:v "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]
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           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 Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)</p></td></tr></tbody></table></div>"^^rdf:XMLLiteral ]
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           ] ;
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         ] )
       ] [
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           fhir:display [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM (NCT03421379)" ]
         ] ;
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           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 ]
         ] ;
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             fhir:value [ fhir:v "NCT03421379-secondaryOutcome-4" ] ;
             fhir:assigner [
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           ] ;
           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)" ] ;
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         fhir:coding ( [
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           ] ;
           fhir:code [ fhir:v "C218531" ] ;
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         fhir:text [ fhir:v "3.3-Exploratory-Objective(s)" ]
       ] ;
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         fhir:status [ fhir:v "additional" ] ;
         fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>"^^rdf:XMLLiteral ]
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       fhir:section ( [
         fhir:title [ fhir:v "3.3.1 Exploratory Objective 1" ] ;
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             ] ;
             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" ]
         ] ;
         fhir:text [
           fhir:status [ fhir:v "additional" ] ;
           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" ]
         ] )
       ] )
     ] )
  ] ) . # 

<http://hl7.org/fhir/uv/ebm/ResearchStudy/267245> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Organization/118079> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Group/267506> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Group/370701> a fhir:Uv .

<http://hl7.org/fhir/uv/ebm/Group/370702> a fhir:Uv .

# -------------------------------------------------------------------------------------