Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379

Raw ttl | Download


@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

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

 a fhir:Evidence ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "267244"] ; # 
  fhir:meta [
fhir:versionId [ fhir:v "9" ] ;
fhir:lastUpdated [ fhir:v "2025-12-11T20:35:21.032Z"^^xsd:dateTime ] ;
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence"^^xsd:anyURI ;
fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/comparative-evidence>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 267244</b></p><a name=\"267244\"> </a><a name=\"hc267244\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 9; Last updated: 2025-12-11 20:35:21+0000; Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-comparative-evidence.html\">ComparativeEvidence</a></p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/Evidence/267244\">https://fevir.net/resources/Evidence/267244</a></p><p><b>identifier</b>: FEvIR Object Identifier/267244, FEvIR Linking Identifier/NCT03421379-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001</p><p><b>name</b>: NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001</p><p><b>title</b>: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379</p><p><b>citeAs</b>: </p><div><p>Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#json.</p>\n</div><p><b>status</b>: Active</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: Computable Publishing LLC</p><p><b>contact</b>: <a href=\"mailto:support@computablepublishing.com\">support@computablepublishing.com</a></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>\n</div><p><b>description</b>: </p><div><p>This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>\n</div><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>All randomized participant who completed both treatment visits and had evaluable treatment success data.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>intended</b>: <a href=\"Group-267225.html\">Group NCT03421379 Eligibility Criteria</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>description</b>: </p><div><p>Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution</p>\n</div><p><b>variableRole</b>: Exposure</p><p><b>comparatorCategory</b>: Glucagon Hydrochloride Solution</p><p><b>observed</b>: Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-267226.html\">Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>note</b>: , </p><blockquote><div><p>Outcome Analysis NonInferiority Type: Non-Inferiority</p>\n</div></blockquote><blockquote><div><p>Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)</p>\n</div></blockquote><p><b>statisticType</b>: <span title=\"Codes:\">Treatment Difference Wald's Method</span></p><p><b>quantity</b>: 0 percentage of participants</p><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Note</b></td><td><b>Type</b></td><td><b>Level</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td><blockquote><div><p>CI Number of Sides: 2-Sided</p>\n</div></blockquote></td><td><span title=\"Codes:{http://terminology.hl7.org/CodeSystem/attribute-estimate-type C53324}\">Confidence interval</span></td><td>0.95</td><td>-1.47-1.47 percentage of participants</td></tr></table></blockquote></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:url [
fhir:v "https://fevir.net/resources/Evidence/267244"^^xsd:anyURI ;
fhir:l <https://fevir.net/resources/Evidence/267244>
  ] ; # 
  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 "267244" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] [
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-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]     ]
  ] ) ; # 
  fhir:name [ fhir:v "NCT03421379_primaryOutcomeMeasure_0_OutcomeAnalysis_0_BetweenGroupAnalysis_OG000_OG001"] ; # 
  fhir:title [ fhir:v "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379"] ; # 
  fhir:citeAs [ fhir:v "Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia at Pre-dose up to 30 minutes post each glucagon administration Statistical Analysis for Glucagon Nasal Powder vs Glucagon Hydrochloride Solution in NCT03421379 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267244. Revised 2025-12-11. Available at: https://fevir.net/resources/Evidence/267244. Computable resource at: https://fevir.net/resources/Evidence/267244#json."] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:author ( [
fhir:name [ fhir:v "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter" ]
  ] ) ; # 
  fhir:publisher [ fhir:v "Computable Publishing LLC"] ; # 
  fhir:contact ( [
    ( fhir:telecom [
fhir:system [ fhir:v "email" ] ;
fhir:value [ fhir:v "support@computablepublishing.com" ]     ] )
  ] ) ; # 
  fhir:copyright [ fhir:v "https://creativecommons.org/licenses/by-nc-sa/4.0/"] ; # 
  fhir:description [ fhir:v "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide."] ; # 
  fhir:variableDefinition ( [
    ( fhir:note [
fhir:text [ fhir:v "All randomized participant who completed both treatment visits and had evaluable treatment success data." ]     ] ) ;
fhir:variableRole [ fhir:v "population" ] ;
fhir:intended [
fhir:l fhir:Group/267225 ;
fhir:reference [ fhir:v "Group/267225" ] ;
fhir:type [
fhir:v "Group"^^xsd:anyURI ;
fhir:l fhir:Group       ] ;
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 Eligibility Criteria" ] ;
fhir:assigner [
fhir:display [ fhir:v "Computable Publishing LLC" ]         ]       ]     ]
  ] [
fhir:description [ fhir:v "Group Assignment: Glucagon Nasal Powder vs. Glucagon Hydrochloride Solution" ] ;
fhir:variableRole [ fhir:v "exposure" ] ;
fhir:comparatorCategory [ fhir:v "Glucagon Hydrochloride Solution" ] ;
fhir:observed [
fhir:display [ fhir:v "Group Assignment: A single dose of 3 mg glucagon nasal powder was administered intranasally vs. A single dose of 1 mg glucagon hydrochloride solution was administered IM" ]     ]
  ] [
fhir:variableRole [ fhir:v "outcome" ] ;
fhir:observed [
fhir:l fhir:EvidenceVariable/267226 ;
fhir:reference [ fhir:v "EvidenceVariable/267226" ] ;
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 at Pre-dose up to 30 minutes post each glucagon administration (NCT03421379)" ]     ]
  ] ) ; # 
  fhir:statistic ( [
    ( fhir:note [
fhir:text [ fhir:v "Outcome Analysis NonInferiority Type: Non-Inferiority" ]     ] [
fhir:text [ fhir:v "Outcome Analysis NonInferiority Comment: The pre-defined non-inferiority margin is (10%)" ]     ] ) ;
fhir:statisticType [
fhir:text [ fhir:v "Treatment Difference Wald's Method" ]     ] ;
fhir:quantity [
fhir:value [ fhir:v "0"^^xsd:decimal ] ;
fhir:unit [ fhir:v "percentage of participants" ]     ] ;
    ( fhir:attributeEstimate [
      ( fhir:note [
fhir:text [ fhir:v "CI Number of Sides: 2-Sided" ]       ] ) ;
fhir:type [
        ( fhir:coding [
fhir:system [
fhir:v "http://terminology.hl7.org/CodeSystem/attribute-estimate-type"^^xsd:anyURI ;
fhir:l <http://terminology.hl7.org/CodeSystem/attribute-estimate-type>           ] ;
fhir:code [ fhir:v "C53324" ] ;
fhir:display [ fhir:v "Confidence interval" ]         ] )       ] ;
fhir:level [ fhir:v 0.95 ] ;
fhir:range [
fhir:low [
fhir:value [ fhir:v -1.47 ] ;
fhir:unit [ fhir:v "percentage of participants" ]         ] ;
fhir:high [
fhir:value [ fhir:v 1.47 ] ;
fhir:unit [ fhir:v "percentage of participants" ]         ]       ]     ] )
  ] ) . #