Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
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
| Page standards status: Informative |
@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:Composition ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "399873"] ; # fhir:meta [ fhir:versionId [ fhir:v "5" ] ; fhir:lastUpdated [ fhir:v "2025-12-11T20:35:21.032Z"^^xsd:dateTime ] ; ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report"^^xsd:anyURI ; fhir:l <http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report> ] ) ] ; # 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: Composition 399873</b></p><a name=\"399873\"> </a><a name=\"hc399873\"> </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: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-outcome-measure-report.html\">OutcomeMeasureReport</a></p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/399873\">https://fevir.net/resources/Composition/399873</a></p><p><b>identifier</b>: FEvIR Object Identifier/399873, FEvIR Linking Identifier/NCT03421379-outcome-measure-report</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 OutcomeMeasureReport}\">Outcome Measure Report</span></p><p><b>date</b>: 2025-12-11 20:35:21+0000</p><p><b>author</b>: [No author listed.]</p><p><b>title</b>: Outcome Measures Report for NCT03421379</p><p><b>custodian</b>: <a href=\"Organization-118079.html\">Computable Publishing LLC</a></p><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Cite As</td><td><div><p>Outcome Measures Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399873. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399873. Computable resource at: https://fevir.net/resources/Composition/399873#json.</p>\n</div></td></tr></table></div>"^^rdf:XMLLiteral ] ] ; # fhir:url [ fhir:v "https://fevir.net/resources/Composition/399873"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/Composition/399873> ] ; # 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 "399873" ] ; 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-outcome-measure-report" ] ; fhir:assigner [ fhir:display [ fhir:v "Computable Publishing LLC" ] ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/CodeSystem/179423> ] ; fhir:code [ fhir:v "OutcomeMeasureReport" ] ; fhir:display [ fhir:v "OutcomeMeasureReport" ] ] ) ; fhir:text [ fhir:v "Outcome Measure Report" ] ] ; # fhir:date [ fhir:v "2025-12-11T20:35:21.032Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:display [ fhir:v "[No author listed.]" ] ] ) ; # fhir:title [ fhir:v "Outcome Measures Report for NCT03421379"] ; # fhir:custodian [ fhir:l fhir: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 "cite-as" ] ; fhir:target [ a fhir:Markdown ; fhir:v "Outcome Measures Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399873. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399873. Computable resource at: https://fevir.net/resources/Composition/399873#json." ] ] ) ; # fhir:section ( [ 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" ] ; fhir:focus [ 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)" ] ] ; 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( fhir:entry [ fhir:display [ fhir:v "A single dose of 3 mg glucagon nasal powder was administered intranasally" ] ] ) ] [ fhir:title [ fhir:v "Glucagon Hydrochloride Solution" ] ; fhir:code [ fhir:text [ fhir:v "OG001" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered IM" ] ] ) ] ) ] [ fhir:title [ fhir:v "Outcome Class List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeClassList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; 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fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered IM" ] ] ) ] ) ] [ fhir:title [ fhir:v "Outcome Class List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeClassList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/CodeSystem/179423> ] ; fhir:code [ fhir:v "results" ] ; fhir:display [ fhir:v "Results" ] ] ) ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267228 ; fhir:reference [ fhir:v "EvidenceVariable/267228" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:entry [ fhir:l fhir:Evidence/267236 ; fhir:reference [ fhir:v "Evidence/267236" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-1--OG000" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379" ] ] [ fhir:l fhir:Evidence/267237 ; fhir:reference [ fhir:v "Evidence/267237" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-1--OG001" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379" ] ] ) ] ) ] ) ] [ fhir:title [ 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration" ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267229 ; fhir:reference [ fhir:v "EvidenceVariable/267229" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Outcome Measure Population Description" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasurePopulationDescription" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Reporting Status" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureReportingStatus" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Time Frame" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureTimeFrame" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Group List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeGroupList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Glucagon Nasal Powder" ] ; fhir:code [ fhir:text [ fhir:v "OG000" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 3 mg glucagon nasal powder was administered intranasally" ] ] ) ] [ fhir:title [ fhir:v "Glucagon Hydrochloride Solution" ] ; fhir:code [ fhir:text [ fhir:v "OG001" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered IM" ] ] ) ] ) ] [ fhir:title [ fhir:v "Outcome Class List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeClassList" ] ] ; ( fhir:section [ fhir:title [ 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/CodeSystem/179423> ] ; fhir:code [ fhir:v "results" ] ; fhir:display [ fhir:v "Results" ] ] ) ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267229 ; fhir:reference [ fhir:v "EvidenceVariable/267229" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:entry [ fhir:l fhir:Evidence/267238 ; fhir:reference [ fhir:v "Evidence/267238" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-2--OG000" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379" ] ] [ fhir:l fhir:Evidence/267239 ; fhir:reference [ fhir:v "Evidence/267239" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-2--OG001" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379" ] ] ) ] ) ] ) ] [ fhir:title [ fhir:v "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration" ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267230 ; fhir:reference [ fhir:v "EvidenceVariable/267230" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Outcome Measure Population Description" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasurePopulationDescription" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Reporting Status" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureReportingStatus" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Time Frame" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureTimeFrame" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Group List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeGroupList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Glucagon Nasal Powder" ] ; fhir:code [ fhir:text [ fhir:v "OG000" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 3 mg glucagon nasal powder was administered intranasally" ] ] ) ] [ fhir:title [ fhir:v "Glucagon Hydrochloride Solution" ] ; fhir:code [ fhir:text [ fhir:v "OG001" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered IM" ] ] ) ] ) ] [ fhir:title [ fhir:v "Outcome Class List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeClassList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/CodeSystem/179423> ] ; fhir:code [ fhir:v "results" ] ; fhir:display [ fhir:v "Results" ] ] ) ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267230 ; fhir:reference [ fhir:v "EvidenceVariable/267230" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:entry [ fhir:l fhir:Evidence/267240 ; fhir:reference [ fhir:v "Evidence/267240" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-3--OG000" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379" ] ] [ fhir:l fhir:Evidence/267241 ; fhir:reference [ fhir:v "Evidence/267241" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-3--OG001" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379" ] ] ) ] ) ] ) ] [ fhir:title [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration" ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267231 ; fhir:reference [ fhir:v "EvidenceVariable/267231" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Outcome Measure Population Description" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasurePopulationDescription" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug and had evaluable PK data.</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Reporting Status" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureReportingStatus" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Posted</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Measure Time Frame" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeMeasureTimeFrame" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration</div>"^^rdf:XMLLiteral ] ] ] [ fhir:title [ fhir:v "Outcome Group List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeGroupList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "Glucagon Nasal Powder" ] ; fhir:code [ fhir:text [ fhir:v "OG000" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 3 mg glucagon nasal powder was administered intranasally" ] ] ) ] [ fhir:title [ fhir:v "Glucagon Hydrochloride Solution" ] ; fhir:code [ fhir:text [ fhir:v "OG001" ] ] ; fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"^^rdf:XMLLiteral ] ] ; ( fhir:entry [ fhir:display [ fhir:v "A single dose of 1 mg glucagon hydrochloride solution was administered IM" ] ] ) ] ) ] [ fhir:title [ fhir:v "Outcome Class List" ] ; fhir:code [ fhir:text [ fhir:v "OutcomeClassList" ] ] ; ( fhir:section [ fhir:title [ fhir:v "PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://fevir.net/resources/CodeSystem/179423"^^xsd:anyURI ; fhir:l <https://fevir.net/resources/CodeSystem/179423> ] ; fhir:code [ fhir:v "results" ] ; fhir:display [ fhir:v "Results" ] ] ) ] ; fhir:focus [ fhir:l fhir:EvidenceVariable/267231 ; fhir:reference [ fhir:v "EvidenceVariable/267231" ] ; 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-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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration (NCT03421379)" ] ] ; ( fhir:entry [ fhir:l fhir:Evidence/267242 ; fhir:reference [ fhir:v "Evidence/267242" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-4--OG000" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Nasal Powder in NCT03421379" ] ] [ fhir:l fhir:Evidence/267243 ; fhir:reference [ fhir:v "Evidence/267243" ] ; fhir:type [ fhir:v "Evidence"^^xsd:anyURI ; fhir:l fhir:Evidence ] ; 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-secondaryOutcomeMeasure-4--OG001" ] ; 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 at Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration for Glucagon Hydrochloride Solution in NCT03421379" ] ] ) ] ) ] ) ] ) . #
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Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
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2026-02-10
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