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 |
{
"resourceType" : "Evidence",
"id" : "267243",
"meta" : {
"versionId" : "14",
"lastUpdated" : "2026-09-02T17:15:21.850Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: Evidence 267243</b></p><a name=\"267243\"> </a><a name=\"hc267243\"> </a><div style=\"display: inline-block; background-color: #fbffeb; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">version: 14; Last updated: 2026-09-02 17:15:21+0000</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>ArtifactPublicationStatus</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/cited-artifact-status-type active}\">Active</span></p><p><b>url</b>: <a href=\"Evidence-267243.html\">Evidence 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</a></p><p><b>identifier</b>: FEvIR Object Identifier/267243, FEvIR Linking Identifier/NCT03421379-secondaryOutcomeMeasure-4--OG001, <a href=\"http://terminology.hl7.org/7.5.0/NamingSystem-uri.html\" title=\"As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt \r\n\r\nThis oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid: \r\n\r\nNote that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.\r\n\r\nThis OID may also be used in CD.codeSystem.\">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.22.257</p><p><b>version</b>: 1.0.0-ballot3</p><p><b>name</b>: NCT03421379_secondaryOutcomeMeasure_4_OG001</p><p><b>title</b>: 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</p><p><b>citeAs</b>: </p><div><p>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 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267243. Revised 2026-09-02. Available at: https://fevir.net/resources/Evidence/267243. Computable resource at: https://fevir.net/resources/Evidence/267243#json.</p>\n</div><p><b>status</b>: Active</p><p><b>date</b>: 2026-11-05 14:34:28+0000</p><p><b>author</b>: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter: </p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href=\"http://www.hl7.org/Special/committees/dss\">http://www.hl7.org/Special/committees/dss</a></p><p><b>copyright</b>: </p><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</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>description</b>: </p><div><p>Glucagon Hydrochloride Solution</p>\n</div><p><b>note</b>: , </p><blockquote><div><p>Outcome Measure Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data.</p>\n</div></blockquote><blockquote><div><p>Outcome Measure Denominator Units: Participants</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: A single dose of 1 mg glucagon hydrochloride solution was administered IM (Identifier: ClinicalTrials.gov Outcome Measurement Group Id/OG001)</p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"EvidenceVariable-267231.html\">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)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000574}\">median</span></p><p><b>quantity</b>: 0.17 hour (h)</p><h3>SampleSizes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>KnownDataCount</b></td></tr><tr><td style=\"display: none\">*</td><td>68</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Range</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Full Range</span></td><td>0.08-0.67 hour (h)</td></tr></table></blockquote></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
"code" : "active",
"display" : "Active"
}
]
}
}
],
"url" : "https://fevir.net/resources/Evidence/267243",
"identifier" : [
{
"type" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
"code" : "ACSN",
"display" : "Accession ID"
}
],
"text" : "FEvIR Object Identifier"
},
"system" : "https://fevir.net/FOI",
"value" : "267243",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcomeMeasure-4--OG001",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"system" : "urn:ietf:rfc:3986",
"value" : "urn:oid:2.16.840.1.113883.4.642.40.44.22.257"
}
],
"version" : "1.0.0-ballot3",
"name" : "NCT03421379_secondaryOutcomeMeasure_4_OG001",
"title" : "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",
"citeAs" : "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 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 267243. Revised 2026-09-02. Available at: https://fevir.net/resources/Evidence/267243. Computable resource at: https://fevir.net/resources/Evidence/267243#json.",
"status" : "active",
"date" : "2026-11-05T14:34:28+00:00",
"author" : [
{
"name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
}
],
"publisher" : "HL7 International / Clinical Decision Support",
"contact" : [
{
"name" : "HL7 International / Clinical Decision Support",
"telecom" : [
{
"system" : "url",
"value" : "http://www.hl7.org/Special/committees/dss"
}
]
}
],
"copyright" : "Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).",
"description" : "This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.",
"variableDefinition" : [
{
"description" : "Glucagon Hydrochloride Solution",
"note" : [
{
"text" : "Outcome Measure Population Description: All randomized participants who received at least one dose of study drug and had evaluable PK data."
},
{
"text" : "Outcome Measure Denominator Units: Participants"
}
],
"variableRole" : "population",
"observed" : {
"identifier" : {
"type" : {
"text" : "ClinicalTrials.gov Outcome Measurement Group Id"
},
"value" : "OG001"
},
"display" : "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"variableRole" : "outcome",
"observed" : {
🔗 "reference" : "EvidenceVariable/267231",
"type" : "EvidenceVariable",
"identifier" : {
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-secondaryOutcome-4",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
"display" : "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)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000574",
"display" : "median"
}
]
},
"quantity" : {
"value" : 0.17,
"unit" : "hour (h)"
},
"sampleSize" : {
"knownDataCount" : 68
},
"attributeEstimate" : [
{
"type" : {
"text" : "Full Range"
},
"range" : {
"low" : {
"value" : 0.08,
"unit" : "hour (h)"
},
"high" : {
"value" : 0.67,
"unit" : "hour (h)"
}
}
}
]
}
]
}