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 2.0.0-ballot 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 Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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

 a fhir:ResearchStudy ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "267245"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "48" ] ;
fhir:lastUpdated [ fhir:v "2024-09-03T18:34:08.592Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "empty" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">[No data.]</div>"
  ] ; # 
  fhir:contained ( [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT03421379-drug------glucagon-nasal-powder" ] ;
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:useContext [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for ClinicalTrials.gov" ]       ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]       ]     ] )
  ] [
a fhir:EvidenceVariable ;
fhir:id [ fhir:v "NCT03421379-drug------glucagon-hydrochloride-solution" ] ;
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:useContext [
fhir:code [
fhir:system [ fhir:v "https://clinicaltrials.gov/data-about-studies/study-data-structure#enum-InterventionType"^^xsd:anyURI ] ;
fhir:code [ fhir:v "interventionType" ] ;
fhir:display [ fhir:v "Intervention Type for ClinicalTrials.gov" ]       ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "DRUG" ]       ]     ] )
  ] [
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"^^xsd:decimal ] ;
fhir:latitude [ fhir:v "33.6"^^xsd:decimal ]     ]
  ] [
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"^^xsd:decimal ] ;
fhir:latitude [ fhir:v "35.6895"^^xsd:decimal ]     ]
  ] [
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"^^xsd:decimal ] ;
fhir:latitude [ fhir:v "35.6895"^^xsd:decimal ]     ]
  ] [
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"^^xsd:decimal ] ;
fhir:latitude [ fhir:v "35.6895"^^xsd:decimal ]     ]
  ] ) ; # 
  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®: ClinicalTrials.gov-to-FEvIR Converter" ]     ]
  ] [
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" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement"^^xsd:anyURI ] ;
fhir:value [ fhir:v "This study does not have a confidentiality statement, but this is an example of how the data would appear if there was such a statement." ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sae-reporting-method"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Report Serious Adverse Events to the sponsor by phone. Refer to Section 9.4 for detailed reporting instructions." ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "details"^^xsd:anyURI ] ;
fhir:value [ fhir:v "This protocol has not been amended previously." ]     ] [
fhir:url [ fhir:v "description"^^xsd:anyURI ] ;
fhir:value [ 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: (1) An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. (2) 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 "rationale"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Updates to address safety concern & align with product guidelines." ]     ] [
fhir:url [ fhir:v "substantialImpactSafety"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] [
fhir:url [ fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Specifically implemented to decrease safety risks." ]     ] [
fhir:url [ fhir:v "substantialImpactReliability"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] [
fhir:url [ fhir:v "primaryReason"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://spor.ema.europa.eu/v1/example-reason"^^xsd:anyURI ] ;
fhir:code [ fhir:v "2" ] ;
fhir:display [ fhir:v "Safety" ]         ] ) ;
fhir:text [ fhir:v "Safety" ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment"^^xsd:anyURI ]
  ] ) ; # 
  fhir:url [ fhir:v "https://fevir.net/resources/ResearchStudy/267245"^^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"^^xsd:anyURI ] ;
fhir:value [ fhir:v "267245" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] [
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:text [ fhir:v "Sponsor Protocol Identifier" ]     ] ;
fhir:value [ fhir:v "I8R-JE-IGBJ" ] ;
fhir:assigner [
fhir:display [ fhir:v "Eli Lilly and Company" ]     ]
  ] [
fhir:type [
fhir:text [ fhir:v "Amendment Identifier" ]     ] ;
fhir:value [ fhir:v "I8R-JE-IGBJ(a)" ]
  ] ) ; # 
  fhir:version [ fhir:v "(a)"] ; # 
  fhir:name [ fhir:v "NCT03421379_FHIR_Transform_M11_IGBJ"] ; # 
  fhir:title [ fhir:v "A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus - M11 Example"] ; # 
  fhir:label ( [
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "official" ] ;
fhir:display [ fhir:v "Official title" ]       ] )     ] ;
fhir:value [ 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:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "acronym" ] ;
fhir:display [ fhir:v "Acronym" ]       ] )     ] ;
fhir:value [ fhir:v "IGBJ" ]
  ] [
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 "M11 IGBJ EXAMPLE" ]
  ] ) ; # 
  fhir:relatedArtifact ( [
fhir:type [ fhir:v "transforms" ] ;
fhir:document [
fhir:url [ fhir:v "https://clinicaltrials.gov/api/v2/studies/NCT03421379?format=json"^^xsd:anyURI ]     ]
  ] [
fhir:type [ fhir:v "transformed-with" ] ;
fhir:display [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ] ;
fhir:document [
fhir:url [ fhir:v "https://fevir.net/resources/Project/29885"^^xsd:anyURI ]     ]
  ] [
fhir:type [ fhir:v "supported-with" ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "IPD Sharing URL" ]     ] ) ;
fhir:document [
fhir:url [ fhir:v "https://www.clinicalstudydatarequest.com"^^xsd:anyURI ]     ]
  ] [
fhir:type [ fhir:v "documentation" ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "Prot" ]     ] ) ;
fhir:label [ fhir:v "Study Protocol" ] ;
fhir:document [
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:creation [ fhir:v "2017-12-05"^^xsd:date ]     ]
  ] [
fhir:type [ fhir:v "documentation" ] ;
    ( fhir:classifier [
fhir:text [ fhir:v "SAP" ]     ] ) ;
fhir:label [ fhir:v "Statistical Analysis Plan" ] ;
fhir:document [
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:creation [ fhir:v "2018-02-02"^^xsd:date ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "American Diabetes Association; Workgroup on Hypoglycemia. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28(5):1245-1249." ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267496" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia." ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "American Diabetes Association. Glycemic targets. Diabetes Care. 2017;40(suppl 1):S48-S56." ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267497" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "6. Glycemic Targets." ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "GlucaGen (glucagon [rDNA origin] for injection) [Summary of Product Characteristics]. Bagsvaerd, Denmark: Novo Nordisk; revised 2015. Available at: https://www.medicines.org.uk/emc/medicine/4258#DOCREVISION. Accessed September 29, 2017." ] ;
fhir:document [
fhir:url [ fhir:v "https://www.medicines.org.uk/emc/medicine/4258#DOCREVISION"^^xsd:anyURI ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Glucagon G Novo for Injection [Package Insert]. Bagsvaerd, Denmark: Novo Nordisk; revised 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/620023_7229402D1036_1_06. Accessed September 28, 2017." ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Glucagon G Novo for Injection [Interview Form]. Bagsvaerd, Denmark: Novo Nordisk; 2015. Available at: http://www.info.pmda.go.jp/go/interview/1/620023_7229402D1036_1_007_1F. Accessed September 28, 2017." ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "GLUCAGON for Injection ITO [Package Insert]. Osaka, Japan: Kaigen Pharma Co., Ltd; 2016. Available at: http://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/130616_7229400D1088_1_11." ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "GLUCAGON for Injection ITO [Interview Form]. Osaka, Japan: Kaigen Pharma Co., Ltd; 2016. Available at: http://www.info.pmda.go.jp/go/interview/1/130616_7229400D1088_1_G07_1F. Accessed September 28, 2017." ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Polonsky WH, Fisher L, Hessler D, Johnson N. Emotional distress in the partners of type 1 diabetes adults: worries about hypoglycemia and other key concerns. Diabetes Technol Ther. 2016;18:292-297." ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267498" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Emotional Distress in the Partners of Type 1 Diabetes Adults: Worries About Hypoglycemia and Other Key Concerns." ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Rickels MR, Ruedy KJ, Foster NC, Piché CA, Dulude H, Sherr JL, Tamborlane WV, Bethin KE, DiMeglio LA, Wadwa RP, Ahmann AJ, Haller MJ, Nathan BM, Marcovina SM, Rampakakis E, Meng L, Beck RW; T1D Exchange Intranasal Glucagon Investigators. Intranasal glucagon for treatment of insulin-induced hypoglycemia in adults with type 1 diabetes: a randomized crossover noninferiority study. Diabetes Care. 2016;39(2):264-270." ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267499" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Intranasal Glucagon for Treatment of Insulin-Induced Hypoglycemia in Adults With Type 1 Diabetes: A Randomized Crossover Noninferiority Study." ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Reno FE, Normand P, McInally K, Silo S, Stotland P, Triest M, Carballo D, Piché C. A novel nasal powder formulation of glucagon: toxicology studies in animal models. BMC Pharmacol Toxicol. 2015;16:29." ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267500" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "A novel nasal powder formulation of glucagon: toxicology studies in animal models." ]     ]
  ] [
fhir:type [ fhir:v "cites" ] ;
fhir:citation [ fhir:v "Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013;36(5):1384-1395" ] ;
fhir:resourceReference [
fhir:reference [ fhir:v "Citation/267501" ] ;
fhir:type [ fhir:v "Citation"^^xsd:anyURI ] ;
fhir:display [ fhir:v "23589542 Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society." ]     ]
  ] ) ; # 
  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://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 "http://hl7.org/fhir/study-design"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01003" ] ;
fhir:display [ fhir:v "randomized assignment" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/study-design"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01012" ] ;
fhir:display [ fhir:v "Crossover cohort design" ]     ] )
  ] [
    ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/study-design"^^xsd:anyURI ] ;
fhir:code [ fhir:v "SEVCO:01001" ] ;
fhir:display [ fhir:v "interventional research" ]     ] )
  ] ) ; # 
  fhir:focus ( [
fhir:concept [
      ( fhir:coding [
fhir:system [ fhir:v "http://example.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "LY900018" ] ;
fhir:display [ fhir:v "Glucagon" ]       ] )     ] ;
fhir:reference [
fhir:type [ fhir:v "SubstanceDefinition"^^xsd:anyURI ] ;
fhir:display [ fhir:v "Glucagon (LY900018)" ]     ]
  ] ) ; # 
  fhir:condition ( [
fhir:text [ fhir:v "Diabetes Mellitus" ]
  ] [
fhir:text [ fhir:v "insulin-induced hypoglycemia" ]
  ] ) ; # 
  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:description [ fhir:v "This ResearchStudy Resource was derived from data in the ClinicalTrials.gov record then modified for use to support an M11 Report."] ; # 
  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:name [ fhir:v "Eli Lilly and Company, Eli Lilly Japan K.K" ] ;
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: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-director" ] ;
fhir:display [ fhir:v "study-director" ]       ] )     ] ;
fhir:party [
fhir:display [ fhir:v "Eli Lilly and Company" ]     ]
  ] [
fhir:name [ fhir:v "Medical Expert details on file at 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 "general-contact" ] ;
fhir:display [ fhir:v "general-contact" ]       ] ) ;
fhir:text [ fhir:v "Medical Expert" ]     ]
  ] ) ; # 
  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"^^xsd:boolean ] ;
fhir:period [
fhir:start [ fhir:v "2018-02-21"^^xsd:date ] ;
fhir:end [ fhir:v "2018-08-20"^^xsd:date ]     ]
  ] [
fhir:state [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-status"^^xsd:anyURI ] ;
fhir:code [ fhir:v "approved" ] ;
fhir:display [ fhir:v "Approved" ]       ] ) ;
fhir:text [ fhir:v "Sponsor Approval" ]     ] ;
fhir:actual [ fhir:v "true"^^xsd:boolean ] ;
fhir:period [
fhir:start [ fhir:v "2017-10-26"^^xsd:date ]     ]
  ] [
fhir:state [
fhir:text [ fhir:v "Version Date" ]     ] ;
fhir:actual [ fhir:v "true"^^xsd:boolean ] ;
fhir:period [
fhir:start [ fhir:v "2017-12-05"^^xsd:date ]     ]
  ] ) ; # 
  fhir:recruitment [
    ( fhir:extension [
fhir:url [ fhir:v "http://example.org/fhir/extension/population-description"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Seventy-five patients may be enrolled in order to have at least 66 patients (at least 30 patients with T1DM and T2DM, respectively) complete the study. For purposes of this study, a completer is defined as a patient who completes both periods with evaluable primary outcome. If patients discontinue from the study before completion of both periods with evaluable primary outcome for any reason, the patient may be replaced to ensure 66 patients complete the study. The replacement patients will be assigned the same treatment sequence as the patients to be replaced and will complete that treatment sequence in its entirety. Replacement should not occur beyond 75 patients enrolled, if it is expected to have at least 66 patients complete the study. Eligibility of patients for the study will be based on the results of screening medical history, physical examination, vital signs, clinical laboratory tests, and ECG. The nature of any conditions present at the time of the physical examination and any preexisting conditions will be documented. Screening may occur up to 28 days prior to enrollment. Patients who are not enrolled within 28 days of screening may be subjected to an additional medical assessment and/or clinical measurements to confirm their eligibility. Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as protocol waivers or exemptions, are not permitted." ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "details"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Male patients must use an effective method of contraception for the duration of the study and for 28 days following the last study treatment. Female patients of childbearing potential must use one highly effective method of contraception (<1% failure rate; such as combined oral contraceptive pill, implanted contraceptives, or intrauterine device) or a combination of 2 effective methods of contraception (such as male or female condoms with spermicide [not approved in Japan], diaphragms with spermicide [not approved in Japan], or cervical sponges) during the study and for 28 days following the last study treatment. The patient may choose to use a double barrier method of contraception. Barrier protection methods without concomitant use of a spermicide are not a reliable or acceptable method. Thus, each barrier method must include use of a spermicide. It should be noted that the use of male and female condoms as a double barrier method is not considered acceptable due to the high failure rate when these methods are combined." ]       ] [
fhir:url [ fhir:v "definitions"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Not defined in protocol." ]       ] ) ;
fhir:url [ fhir:v "http://example.org/fhir/extension/recruitment-contraception"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "lifestyle-summary"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Throughout the study, patients may undergo medical assessments and review of compliance with requirements before continuing in the study." ]       ] [
fhir:url [ fhir:v "dietary"^^xsd:anyURI ] ;
fhir:value [ fhir:v "In both treatment periods, patients will fast for at least 8 hours prior to beginning the hypoglycemia induction procedure. Patients should not be given any calorie-containing food/drink during insulin-induced hypoglycemia and within 90 minutes of glucagon administration unless there is a safety concern. The patients will receive a carbohydrate-rich meal after completion of all pharmacokinetic (PK) blood sample collections, at 240 minutes post glucagon dose. Patients will be given access to calorie-free water up to 240 minutes post study treatment. While resident in the CRU, patients should not consume any food or caloric drinks other than that provided by the CRU. When not resident in the CRU, patients will be encouraged to follow their normal diets" ]       ] [
fhir:url [ fhir:v "substances"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Patients should refrain from caffeine-containing food/beverages (eg, cola, chocolate drinks, tea, and coffee) from Day -1 to discharge from CRU in each period. Patient alcohol intake should not exceed 21 units per week (males up to age 65) and 14 units per week (males over 65 and females) during the study. Patients must not consume alcohol from Day -2 to discharge from CRU in each period. Smoking will not be permitted when resident in the CRU." ]       ] [
fhir:url [ fhir:v "activity"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Patients are encouraged to maintain their regular exercise habits for the duration of the study. However, patients should avoid strenuous exercise 48 hours prior to admission or study visit. From the beginning of hypoglycemia induction to 240 minutes post study treatment, patients should remain recumbent or sitting on the bed." ]       ] [
fhir:url [ fhir:v "other"^^xsd:anyURI ] ;
fhir:value [ fhir:v "[Optional section not used here.]" ]       ] ) ;
fhir:url [ fhir:v "http://example.org/fhir/extension/recruitment-restrictions"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "http://example.org/fhir/extension/screen-failure"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Individuals who do not meet the criteria for participation in this study (screen failure) may not be re-screened." ]     ] ) ;
fhir:targetNumber [ fhir:v "20"^^xsd:nonNegativeInteger ] ;
fhir:actualNumber [ fhir:v "75"^^xsd:nonNegativeInteger ] ;
fhir:eligibility [
fhir:reference [ fhir:v "Group/267506" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "M11 IGBJ Protocol Example Eligibility Criteria" ]     ]
  ] ; # 
  fhir:comparisonGroup ( [
fhir:linkId [ fhir:v "nasal" ] ;
fhir:name [ fhir:v "Glucagon Nasal Powder" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-arm-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "experimental" ] ;
fhir:display [ fhir:v "Experimental" ]       ] )     ] ;
fhir:description [ fhir:v "A single dose of 3 milligram (mg) glucagon nasal powder administered intranasally." ] ;
    ( fhir:intendedExposure [
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:linkId [ fhir:v "solution" ] ;
fhir:name [ fhir:v "Glucagon Hydrochloride Solution" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-arm-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "active-comparator" ] ;
fhir:display [ fhir:v "Active Comparator" ]       ] )     ] ;
fhir:description [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered intramuscular (IM)" ] ;
    ( fhir:intendedExposure [
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:objective ( [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "label"^^xsd:anyURI ] ;
fhir:value [ fhir:v "Proportion achieving treatment success" ]       ] [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ fhir:v "The proportion of patients achieving treatment success defined as either an increase in PG to >70 mg/dL or an increase of >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." ]         ]       ] [
fhir:url [ fhir:v "population"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Group/267506" ] ;
fhir:type [ fhir:v "Group"^^xsd:anyURI ] ;
fhir:display [ fhir:v "M11 IGBJ Protocol Example Eligibility Criteria" ]         ]       ] [
fhir:url [ fhir:v "interventionGroup"^^xsd:anyURI ] ;
fhir:value [ fhir:v "nasal" ]       ] [
fhir:url [ fhir:v "comparatorGroup"^^xsd:anyURI ] ;
fhir:value [ fhir:v "solution" ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] ) ;
fhir:name [ fhir:v "Treatment success" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "primary" ] ;
fhir:display [ fhir:v "Primary" ]       ] )     ] ;
fhir:description [ fhir:v "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%" ]
  ] [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "serious adverse events (SAEs)" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "label"^^xsd:anyURI ] ;
fhir:value [ fhir:v "treatment-emergent adverse events (TEAEs)" ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "treatment-emergent adverse events (TEAEs) (including gastrointestinal, nasal, and non-nasal AEs)" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "vital signs" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] ) ;
fhir:name [ fhir:v "Safety and tolerability" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ] ;
fhir:description [ fhir:v "To compare the safety and tolerability of 3 mg LY900018 with 1 mg IMG" ]
  ] [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ fhir:v "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ fhir:v "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ 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:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ fhir:v "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "type"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]           ] )         ]       ] [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
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:display [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] ) ;
fhir:name [ fhir:v "To characterize the PK profile of 3 mg LY900018 compared to 1 mg IMG" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "secondary" ] ;
fhir:display [ fhir:v "Secondary" ]       ] )     ] ;
fhir:description [ fhir:v "PK parameters include AUC, Cmax, Tmax PD parameters include BGmax and Tmax" ]
  ] [
    ( fhir:extension [
      ( fhir:extension [
fhir:url [ fhir:v "endpoint"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "Presence of anti-glucagon antibodies" ]         ]       ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-estimand"^^xsd:anyURI ]     ] ) ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "exploratory" ] ;
fhir:display [ fhir:v "Exploratory" ]       ] )     ] ;
fhir:description [ fhir:v "Explore the formation of anti-glucagon antibodies to glucagon" ]
  ] [
fhir:name [ fhir:v "To evaluate the recovery from clinical symptoms of hypoglycemia" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/research-study-objective-type"^^xsd:anyURI ] ;
fhir:code [ fhir:v "exploratory" ] ;
fhir:display [ fhir:v "Exploratory" ]       ] )     ] ;
fhir:description [ fhir:v "Hypoglycemia symptoms questionnaire" ]
  ] ) ; # 
  fhir:result ( [
fhir:type [ fhir:v "EvidenceReport"^^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" ]
  ] ) . #