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
{
"resourceType" : "Composition",
"id" : "399872",
"meta" : {
"versionId" : "5",
"lastUpdated" : "2025-12-11T20:35:21.032Z",
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/baseline-measure-report"
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: Composition 399872</b></p><a name=\"399872\"> </a><a name=\"hc399872\"> </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-baseline-measure-report.html\">BaselineMeasureReport</a></p></div><p><b>url</b>: <a href=\"https://fevir.net/resources/Composition/399872\">https://fevir.net/resources/Composition/399872</a></p><p><b>identifier</b>: FEvIR Object Identifier/399872, FEvIR Linking Identifier/NCT03421379-baseline-measure-report</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 BaselineMeasureReport}\">Baseline 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>: Baseline Characteristics 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>Baseline Characteristics Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399872. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399872. Computable resource at: https://fevir.net/resources/Composition/399872#json.</p>\n</div></td></tr></table><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-0</b></p><a name=\"399872/NCT03421379-BaselineMeasure-0\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-0\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>title</b>: Age, Continuous</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Age, Continuous</span></td></tr></table><p><b>handling</b>: extension</p><p><b>classifier</b>: <span title=\"Codes:\">Baseline Measure</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Offset[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>No display for Duration (value: 0)</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-1</b></p><a name=\"399872/NCT03421379-BaselineMeasure-1\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-1\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>title</b>: Sex: Female, Male</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Sex: Female, Male</span></td></tr></table><p><b>handling</b>: extension</p><blockquote><p><b>category</b></p><p><b>name</b>: Female</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Male</p></blockquote><p><b>classifier</b>: <span title=\"Codes:\">Baseline Measure</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Offset[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>No display for Duration (value: 0)</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-2</b></p><a name=\"399872/NCT03421379-BaselineMeasure-2\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-2\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>title</b>: Ethnicity (NIH/OMB)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Ethnicity (NIH/OMB)</span></td></tr></table><p><b>handling</b>: extension</p><blockquote><p><b>category</b></p><p><b>name</b>: Hispanic or Latino</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Not Hispanic or Latino</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Unknown or Not Reported</p></blockquote><p><b>classifier</b>: <span title=\"Codes:\">Baseline Measure</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Offset[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>No display for Duration (value: 0)</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-3</b></p><a name=\"399872/NCT03421379-BaselineMeasure-3\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-3\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>title</b>: Race (NIH/OMB)</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Race (NIH/OMB)</span></td></tr></table><p><b>handling</b>: extension</p><blockquote><p><b>category</b></p><p><b>name</b>: American Indian or Alaska Native</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Asian</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Native Hawaiian or Other Pacific Islander</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Black or African American</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: White</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: More than one race</p></blockquote><blockquote><p><b>category</b></p><p><b>name</b>: Unknown or Not Reported</p></blockquote><p><b>classifier</b>: <span title=\"Codes:\">Baseline Measure</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Offset[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>No display for Duration (value: 0)</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-4</b></p><a name=\"399872/NCT03421379-BaselineMeasure-4\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-4\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-variable-definition.html\">VariableDefinition</a></p></div><p><b>EvidenceVariableHandlingDetail</b>: <span title=\"Codes:{https://fevir.net/resources/CodeSystem/179423 evidence-variable-handling-not-specified}\">Evidence variable handling not specified</span></p><p><b>title</b>: Region of Enrollment</p><p><b>status</b>: Active</p><h3>Definitions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Region of Enrollment</span></td></tr></table><p><b>handling</b>: extension</p><h3>Categories</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td></tr><tr><td style=\"display: none\">*</td><td>Japan</td></tr></table><p><b>classifier</b>: <span title=\"Codes:\">Baseline Measure</span></p><h3>Timings</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Offset[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>No display for Duration (value: 0)</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Group #BG000</b></p><a name=\"399872/BG000\"> </a><a name=\"hc399872/BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-exposure-group.html\">ExposureGroup</a></p></div><p><b>name</b>: Glucagon Nasal Powder/Glucagon Hydrochloride Solution</p><p><b>description</b>: </p><div><p>A single dose of 3 mg glucagon nasal powder was administered intranasally</p>\n</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>code</b>: <span title=\"Codes:\">Participants</span></p><p><b>quantity</b>: 33</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Research Study from which this is a baseline group</span></td><td>NCT03421379</td><td>false</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Group #BG001</b></p><a name=\"399872/BG001\"> </a><a name=\"hc399872/BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-exposure-group.html\">ExposureGroup</a></p></div><p><b>name</b>: Glucagon Hydrochloride Solution/Glucagon Nasal Powder</p><p><b>description</b>: </p><div><p>A single dose of 1 mg glucagon hydrochloride solution was administered IM</p>\n</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>code</b>: <span title=\"Codes:\">Participants</span></p><p><b>quantity</b>: 39</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Research Study from which this is a baseline group</span></td><td>NCT03421379</td><td>false</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Group #BG002</b></p><a name=\"399872/BG002\"> </a><a name=\"hc399872/BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-exposure-group.html\">ExposureGroup</a></p></div><p><b>name</b>: Total</p><p><b>description</b>: </p><div><p>Total of all reporting groups</p>\n</div><p><b>type</b>: Person</p><p><b>membership</b>: Enumerated</p><p><b>code</b>: <span title=\"Codes:\">Participants</span></p><p><b>quantity</b>: 72</p><h3>Characteristics</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td><td><b>Value[x]</b></td><td><b>Exclude</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Research Study from which this is a baseline group</span></td><td>NCT03421379</td><td>false</td></tr></table></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG000</b></p><a name=\"399872/NCT03421379-BaselineMeasure-0-BG000\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-0-BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_0_BG000</p><p><b>title</b>: Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG000\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-0\">Age, Continuous</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000573}\">mean</span></p><p><b>quantity</b>: 41.7 years</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>33</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Standard Deviation</span></td><td>11.6 years</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG001</b></p><a name=\"399872/NCT03421379-BaselineMeasure-0-BG001\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-0-BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_0_BG001</p><p><b>title</b>: Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG001\">Glucagon Hydrochloride Solution/Glucagon Nasal Powder</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-0\">Age, Continuous</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000573}\">mean</span></p><p><b>quantity</b>: 57.5 years</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>39</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Standard Deviation</span></td><td>9.2 years</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG002</b></p><a name=\"399872/NCT03421379-BaselineMeasure-0-BG002\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-0-BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_0_BG002</p><p><b>title</b>: Age, Continuous for Total at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG002\">Total</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-0\">Age, Continuous</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000573}\">mean</span></p><p><b>quantity</b>: 50.2 years</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>72</td></tr></table><h3>AttributeEstimates</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Quantity</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Standard Deviation</span></td><td>13 years</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG000</b></p><a name=\"399872/NCT03421379-BaselineMeasure-1-BG000\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-1-BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_1_BG000</p><p><b>title</b>: Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG000\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-1\">Sex: Female, Male</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Female</span></p><p><b>quantity</b>: 13 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Male</span></p><p><b>quantity</b>: 20 Participants</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>33</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG001</b></p><a name=\"399872/NCT03421379-BaselineMeasure-1-BG001\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-1-BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_1_BG001</p><p><b>title</b>: Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG001\">Glucagon Hydrochloride Solution/Glucagon Nasal Powder</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-1\">Sex: Female, Male</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Female</span></p><p><b>quantity</b>: 9 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Male</span></p><p><b>quantity</b>: 30 Participants</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>39</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG002</b></p><a name=\"399872/NCT03421379-BaselineMeasure-1-BG002\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-1-BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_1_BG002</p><p><b>title</b>: Sex: Female, Male for Total at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG002\">Total</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-1\">Sex: Female, Male</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Female</span></p><p><b>quantity</b>: 22 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Male</span></p><p><b>quantity</b>: 50 Participants</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>72</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG000</b></p><a name=\"399872/NCT03421379-BaselineMeasure-2-BG000\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-2-BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_2_BG000</p><p><b>title</b>: Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG000\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-2\">Ethnicity (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Hispanic or Latino</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Not Hispanic or Latino</span></p><p><b>quantity</b>: 33 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG001</b></p><a name=\"399872/NCT03421379-BaselineMeasure-2-BG001\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-2-BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_2_BG001</p><p><b>title</b>: Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG001\">Glucagon Hydrochloride Solution/Glucagon Nasal Powder</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-2\">Ethnicity (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Hispanic or Latino</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Not Hispanic or Latino</span></p><p><b>quantity</b>: 39 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG002</b></p><a name=\"399872/NCT03421379-BaselineMeasure-2-BG002\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-2-BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_2_BG002</p><p><b>title</b>: Ethnicity (NIH/OMB) for Total at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG002\">Total</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-2\">Ethnicity (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Hispanic or Latino</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Not Hispanic or Latino</span></p><p><b>quantity</b>: 72 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG000</b></p><a name=\"399872/NCT03421379-BaselineMeasure-3-BG000\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-3-BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_3_BG000</p><p><b>title</b>: Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG000\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-3\">Race (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">American Indian or Alaska Native</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Asian</span></p><p><b>quantity</b>: 33 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Native Hawaiian or Other Pacific Islander</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Black or African American</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">White</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">More than one race</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>33</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG001</b></p><a name=\"399872/NCT03421379-BaselineMeasure-3-BG001\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-3-BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_3_BG001</p><p><b>title</b>: Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG001\">Glucagon Hydrochloride Solution/Glucagon Nasal Powder</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-3\">Race (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">American Indian or Alaska Native</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Asian</span></p><p><b>quantity</b>: 39 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Native Hawaiian or Other Pacific Islander</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Black or African American</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">White</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">More than one race</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>39</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG002</b></p><a name=\"399872/NCT03421379-BaselineMeasure-3-BG002\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-3-BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_3_BG002</p><p><b>title</b>: Race (NIH/OMB) for Total at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG002\">Total</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-3\">Race (NIH/OMB)</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">American Indian or Alaska Native</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Asian</span></p><p><b>quantity</b>: 72 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Native Hawaiian or Other Pacific Islander</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Black or African American</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">White</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">More than one race</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:{https://fevir.net/sevco STATO:0000047}\">Count of Participants</span></p><p><b>category</b>: <span title=\"Codes:\">Unknown or Not Reported</span></p><p><b>quantity</b>: 0 Participants</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>72</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG000</b></p><a name=\"399872/NCT03421379-BaselineMeasure-4-BG000\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-4-BG000\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_4_BG000</p><p><b>title</b>: Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG000\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-4\">Region of Enrollment</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:\">Number (see protocol for details)</span></p><p><b>category</b>: <span title=\"Codes:\">Japan</span></p><p><b>quantity</b>: 33 participants</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>33</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG001</b></p><a name=\"399872/NCT03421379-BaselineMeasure-4-BG001\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-4-BG001\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_4_BG001</p><p><b>title</b>: Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG001\">Glucagon Hydrochloride Solution/Glucagon Nasal Powder</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-4\">Region of Enrollment</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:\">Number (see protocol for details)</span></p><p><b>category</b>: <span title=\"Codes:\">Japan</span></p><p><b>quantity</b>: 39 participants</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>39</td></tr></table></blockquote></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG002</b></p><a name=\"399872/NCT03421379-BaselineMeasure-4-BG002\"> </a><a name=\"hc399872/NCT03421379-BaselineMeasure-4-BG002\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-non-comparative-evidence.html\">NonComparativeEvidence</a></p></div><p><b>name</b>: NCT03421379_BaselineMeasure_4_BG002</p><p><b>title</b>: Region of Enrollment for Total at baseline in NCT03421379</p><p><b>status</b>: Active</p><blockquote><p><b>variableDefinition</b></p><p><b>note</b>: </p><blockquote><div><p>Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.</p>\n</div></blockquote><p><b>variableRole</b>: Population</p><p><b>observed</b>: <a href=\"#hc399872/BG002\">Total</a></p></blockquote><blockquote><p><b>variableDefinition</b></p><p><b>variableRole</b>: Outcome</p><p><b>observed</b>: <a href=\"#hc399872/NCT03421379-BaselineMeasure-4\">Region of Enrollment</a></p></blockquote><blockquote><p><b>statistic</b></p><p><b>statisticType</b>: <span title=\"Codes:\">Number (see protocol for details)</span></p><p><b>category</b>: <span title=\"Codes:\">Japan</span></p><p><b>quantity</b>: 72 participants</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>72</td></tr></table></blockquote></blockquote></div>"
},
"contained" : [
{
"resourceType" : "EvidenceVariable",
"id" : "NCT03421379-BaselineMeasure-0",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-variable-handling-not-specified",
"display" : "Evidence variable handling not specified"
}
]
}
}
],
"title" : "Age, Continuous",
"status" : "active",
"definition" : {
"concept" : {
"text" : "Age, Continuous"
}
},
"handling" : "extension",
"classifier" : [
{
"text" : "Baseline Measure"
}
],
"timing" : {
"offsetDuration" : {
"value" : 0
}
}
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT03421379-BaselineMeasure-1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-variable-handling-not-specified",
"display" : "Evidence variable handling not specified"
}
]
}
}
],
"title" : "Sex: Female, Male",
"status" : "active",
"definition" : {
"concept" : {
"text" : "Sex: Female, Male"
}
},
"handling" : "extension",
"category" : [
{
"name" : "Female"
},
{
"name" : "Male"
}
],
"classifier" : [
{
"text" : "Baseline Measure"
}
],
"timing" : {
"offsetDuration" : {
"value" : 0
}
}
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT03421379-BaselineMeasure-2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-variable-handling-not-specified",
"display" : "Evidence variable handling not specified"
}
]
}
}
],
"title" : "Ethnicity (NIH/OMB)",
"status" : "active",
"definition" : {
"concept" : {
"text" : "Ethnicity (NIH/OMB)"
}
},
"handling" : "extension",
"category" : [
{
"name" : "Hispanic or Latino"
},
{
"name" : "Not Hispanic or Latino"
},
{
"name" : "Unknown or Not Reported"
}
],
"classifier" : [
{
"text" : "Baseline Measure"
}
],
"timing" : {
"offsetDuration" : {
"value" : 0
}
}
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT03421379-BaselineMeasure-3",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-variable-handling-not-specified",
"display" : "Evidence variable handling not specified"
}
]
}
}
],
"title" : "Race (NIH/OMB)",
"status" : "active",
"definition" : {
"concept" : {
"text" : "Race (NIH/OMB)"
}
},
"handling" : "extension",
"category" : [
{
"name" : "American Indian or Alaska Native"
},
{
"name" : "Asian"
},
{
"name" : "Native Hawaiian or Other Pacific Islander"
},
{
"name" : "Black or African American"
},
{
"name" : "White"
},
{
"name" : "More than one race"
},
{
"name" : "Unknown or Not Reported"
}
],
"classifier" : [
{
"text" : "Baseline Measure"
}
],
"timing" : {
"offsetDuration" : {
"value" : 0
}
}
},
{
"resourceType" : "EvidenceVariable",
"id" : "NCT03421379-BaselineMeasure-4",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-variable-handling-detail",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "evidence-variable-handling-not-specified",
"display" : "Evidence variable handling not specified"
}
]
}
}
],
"title" : "Region of Enrollment",
"status" : "active",
"definition" : {
"concept" : {
"text" : "Region of Enrollment"
}
},
"handling" : "extension",
"category" : [
{
"name" : "Japan"
}
],
"classifier" : [
{
"text" : "Baseline Measure"
}
],
"timing" : {
"offsetDuration" : {
"value" : 0
}
}
},
{
"resourceType" : "Group",
"id" : "BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
]
},
"name" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution",
"description" : "A single dose of 3 mg glucagon nasal powder was administered intranasally",
"type" : "person",
"membership" : "enumerated",
"code" : {
"text" : "Participants"
},
"quantity" : 33,
"characteristic" : [
{
"code" : {
"text" : "Research Study from which this is a baseline group"
},
"valueReference" : {
"display" : "NCT03421379"
},
"exclude" : false
}
]
},
{
"resourceType" : "Group",
"id" : "BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
]
},
"name" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder",
"description" : "A single dose of 1 mg glucagon hydrochloride solution was administered IM",
"type" : "person",
"membership" : "enumerated",
"code" : {
"text" : "Participants"
},
"quantity" : 39,
"characteristic" : [
{
"code" : {
"text" : "Research Study from which this is a baseline group"
},
"valueReference" : {
"display" : "NCT03421379"
},
"exclude" : false
}
]
},
{
"resourceType" : "Group",
"id" : "BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group"
]
},
"name" : "Total",
"description" : "Total of all reporting groups",
"type" : "person",
"membership" : "enumerated",
"code" : {
"text" : "Participants"
},
"quantity" : 72,
"characteristic" : [
{
"code" : {
"text" : "Research Study from which this is a baseline group"
},
"valueReference" : {
"display" : "NCT03421379"
},
"exclude" : false
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-0-BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_0_BG000",
"title" : "Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-0",
"type" : "EvidenceVariable",
"display" : "Age, Continuous"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000573",
"display" : "mean"
}
]
},
"quantity" : {
"value" : 41.7,
"unit" : "years"
},
"sampleSize" : {
"knownDataCount" : 33
},
"attributeEstimate" : [
{
"type" : {
"text" : "Standard Deviation"
},
"quantity" : {
"value" : 11.6,
"unit" : "years"
}
}
]
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-0-BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_0_BG001",
"title" : "Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-0",
"type" : "EvidenceVariable",
"display" : "Age, Continuous"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000573",
"display" : "mean"
}
]
},
"quantity" : {
"value" : 57.5,
"unit" : "years"
},
"sampleSize" : {
"knownDataCount" : 39
},
"attributeEstimate" : [
{
"type" : {
"text" : "Standard Deviation"
},
"quantity" : {
"value" : 9.2,
"unit" : "years"
}
}
]
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-0-BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_0_BG002",
"title" : "Age, Continuous for Total at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-0",
"type" : "EvidenceVariable",
"display" : "Age, Continuous"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000573",
"display" : "mean"
}
]
},
"quantity" : {
"value" : 50.2,
"unit" : "years"
},
"sampleSize" : {
"knownDataCount" : 72
},
"attributeEstimate" : [
{
"type" : {
"text" : "Standard Deviation"
},
"quantity" : {
"value" : 13,
"unit" : "years"
}
}
]
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-1-BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_1_BG000",
"title" : "Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-1",
"type" : "EvidenceVariable",
"display" : "Sex: Female, Male"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Female"
},
"quantity" : {
"value" : 13,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Male"
},
"quantity" : {
"value" : 20,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-1-BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_1_BG001",
"title" : "Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-1",
"type" : "EvidenceVariable",
"display" : "Sex: Female, Male"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Female"
},
"quantity" : {
"value" : 9,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Male"
},
"quantity" : {
"value" : 30,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-1-BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_1_BG002",
"title" : "Sex: Female, Male for Total at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-1",
"type" : "EvidenceVariable",
"display" : "Sex: Female, Male"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Female"
},
"quantity" : {
"value" : 22,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Male"
},
"quantity" : {
"value" : 50,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-2-BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_2_BG000",
"title" : "Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-2",
"type" : "EvidenceVariable",
"display" : "Ethnicity (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Hispanic or Latino"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Not Hispanic or Latino"
},
"quantity" : {
"value" : 33,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-2-BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_2_BG001",
"title" : "Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-2",
"type" : "EvidenceVariable",
"display" : "Ethnicity (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Hispanic or Latino"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Not Hispanic or Latino"
},
"quantity" : {
"value" : 39,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-2-BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_2_BG002",
"title" : "Ethnicity (NIH/OMB) for Total at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-2",
"type" : "EvidenceVariable",
"display" : "Ethnicity (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Hispanic or Latino"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Not Hispanic or Latino"
},
"quantity" : {
"value" : 72,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-3-BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_3_BG000",
"title" : "Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-3",
"type" : "EvidenceVariable",
"display" : "Race (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "American Indian or Alaska Native"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Asian"
},
"quantity" : {
"value" : 33,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Native Hawaiian or Other Pacific Islander"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Black or African American"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "White"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "More than one race"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-3-BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_3_BG001",
"title" : "Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-3",
"type" : "EvidenceVariable",
"display" : "Race (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "American Indian or Alaska Native"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Asian"
},
"quantity" : {
"value" : 39,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Native Hawaiian or Other Pacific Islander"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Black or African American"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "White"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "More than one race"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-3-BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_3_BG002",
"title" : "Race (NIH/OMB) for Total at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-3",
"type" : "EvidenceVariable",
"display" : "Race (NIH/OMB)"
}
}
],
"statistic" : [
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "American Indian or Alaska Native"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Asian"
},
"quantity" : {
"value" : 72,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Native Hawaiian or Other Pacific Islander"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Black or African American"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "White"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "More than one race"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
},
{
"statisticType" : {
"coding" : [
{
"system" : "https://fevir.net/sevco",
"code" : "STATO:0000047",
"display" : "count"
}
],
"text" : "Count of Participants"
},
"category" : {
"text" : "Unknown or Not Reported"
},
"quantity" : {
"value" : 0,
"unit" : "Participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-4-BG000",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_4_BG000",
"title" : "Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-4",
"type" : "EvidenceVariable",
"display" : "Region of Enrollment"
}
}
],
"statistic" : [
{
"statisticType" : {
"text" : "Number (see protocol for details)"
},
"category" : {
"text" : "Japan"
},
"quantity" : {
"value" : 33,
"unit" : "participants"
},
"sampleSize" : {
"knownDataCount" : 33
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-4-BG001",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_4_BG001",
"title" : "Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-4",
"type" : "EvidenceVariable",
"display" : "Region of Enrollment"
}
}
],
"statistic" : [
{
"statisticType" : {
"text" : "Number (see protocol for details)"
},
"category" : {
"text" : "Japan"
},
"quantity" : {
"value" : 39,
"unit" : "participants"
},
"sampleSize" : {
"knownDataCount" : 39
}
}
]
},
{
"resourceType" : "Evidence",
"id" : "NCT03421379-BaselineMeasure-4-BG002",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name" : "NCT03421379_BaselineMeasure_4_BG002",
"title" : "Region of Enrollment for Total at baseline in NCT03421379",
"status" : "active",
"variableDefinition" : [
{
"note" : [
{
"text" : "Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug."
}
],
"variableRole" : "population",
"observed" : {
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
},
{
"variableRole" : "outcome",
"observed" : {
"reference" : "#NCT03421379-BaselineMeasure-4",
"type" : "EvidenceVariable",
"display" : "Region of Enrollment"
}
}
],
"statistic" : [
{
"statisticType" : {
"text" : "Number (see protocol for details)"
},
"category" : {
"text" : "Japan"
},
"quantity" : {
"value" : 72,
"unit" : "participants"
},
"sampleSize" : {
"knownDataCount" : 72
}
}
]
}
],
"url" : "https://fevir.net/resources/Composition/399872",
"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" : "399872",
"assigner" : {
"display" : "Computable Publishing LLC"
}
},
{
"type" : {
"text" : "FEvIR Linking Identifier"
},
"system" : "https://fevir.net/FLI",
"value" : "NCT03421379-baseline-measure-report",
"assigner" : {
"display" : "Computable Publishing LLC"
}
}
],
"status" : "final",
"type" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "BaselineMeasureReport",
"display" : "BaselineMeasureReport"
}
],
"text" : "Baseline Measure Report"
},
"date" : "2025-12-11T20:35:21.032Z",
"author" : [
{
"display" : "[No author listed.]"
}
],
"title" : "Baseline Characteristics Report for NCT03421379",
"custodian" : {
🔗 "reference" : "Organization/118079",
"type" : "Organization",
"display" : "Computable Publishing LLC"
},
"relatesTo" : [
{
"type" : "cite-as",
"targetMarkdown" : "Baseline Characteristics Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399872. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399872. Computable resource at: https://fevir.net/resources/Composition/399872#json."
}
],
"section" : [
{
"title" : "Baseline Reporting Population Description",
"code" : {
"text" : "BaselinePopulationDescription"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug.</div>"
}
},
{
"title" : "Baseline Group List",
"code" : {
"text" : "BaselineGroupList"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">Glucagon Nasal Powder/Glucagon Hydrochloride Solution, Glucagon Hydrochloride Solution/Glucagon Nasal Powder, Total</div>"
},
"entry" : [
{
"reference" : "#BG000",
"type" : "Group",
"display" : "Glucagon Nasal Powder/Glucagon Hydrochloride Solution"
},
{
"reference" : "#BG001",
"type" : "Group",
"display" : "Glucagon Hydrochloride Solution/Glucagon Nasal Powder"
},
{
"reference" : "#BG002",
"type" : "Group",
"display" : "Total"
}
]
},
{
"title" : "Age, Continuous",
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "results",
"display" : "Results"
}
]
},
"focus" : {
"reference" : "#NCT03421379-BaselineMeasure-0",
"type" : "EvidenceVariable",
"display" : "Age, Continuous"
},
"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry" : [
{
"reference" : "#NCT03421379-BaselineMeasure-0-BG000",
"type" : "Evidence",
"display" : "Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-0-BG001",
"type" : "Evidence",
"display" : "Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-0-BG002",
"type" : "Evidence",
"display" : "Age, Continuous for Total at baseline in NCT03421379"
}
]
},
{
"title" : "Sex: Female, Male",
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "results",
"display" : "Results"
}
]
},
"focus" : {
"reference" : "#NCT03421379-BaselineMeasure-1",
"type" : "EvidenceVariable",
"display" : "Sex: Female, Male"
},
"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry" : [
{
"reference" : "#NCT03421379-BaselineMeasure-1-BG000",
"type" : "Evidence",
"display" : "Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-1-BG001",
"type" : "Evidence",
"display" : "Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-1-BG002",
"type" : "Evidence",
"display" : "Sex: Female, Male for Total at baseline in NCT03421379"
}
],
"section" : [
{
"title" : "Baseline Measure Calculate Percent",
"code" : {
"text" : "BaselineMeasureCalculatePct"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
}
}
]
},
{
"title" : "Ethnicity (NIH/OMB)",
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "results",
"display" : "Results"
}
]
},
"focus" : {
"reference" : "#NCT03421379-BaselineMeasure-2",
"type" : "EvidenceVariable",
"display" : "Ethnicity (NIH/OMB)"
},
"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry" : [
{
"reference" : "#NCT03421379-BaselineMeasure-2-BG000",
"type" : "Evidence",
"display" : "Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-2-BG001",
"type" : "Evidence",
"display" : "Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-2-BG002",
"type" : "Evidence",
"display" : "Ethnicity (NIH/OMB) for Total at baseline in NCT03421379"
}
],
"section" : [
{
"title" : "Baseline Measure Calculate Percent",
"code" : {
"text" : "BaselineMeasureCalculatePct"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
}
}
]
},
{
"title" : "Race (NIH/OMB)",
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "results",
"display" : "Results"
}
]
},
"focus" : {
"reference" : "#NCT03421379-BaselineMeasure-3",
"type" : "EvidenceVariable",
"display" : "Race (NIH/OMB)"
},
"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry" : [
{
"reference" : "#NCT03421379-BaselineMeasure-3-BG000",
"type" : "Evidence",
"display" : "Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-3-BG001",
"type" : "Evidence",
"display" : "Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-3-BG002",
"type" : "Evidence",
"display" : "Race (NIH/OMB) for Total at baseline in NCT03421379"
}
],
"section" : [
{
"title" : "Baseline Measure Calculate Percent",
"code" : {
"text" : "BaselineMeasureCalculatePct"
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
}
}
]
},
{
"title" : "Region of Enrollment",
"code" : {
"coding" : [
{
"system" : "https://fevir.net/resources/CodeSystem/179423",
"code" : "results",
"display" : "Results"
}
]
},
"focus" : {
"reference" : "#NCT03421379-BaselineMeasure-4",
"type" : "EvidenceVariable",
"display" : "Region of Enrollment"
},
"text" : {
"status" : "empty",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry" : [
{
"reference" : "#NCT03421379-BaselineMeasure-4-BG000",
"type" : "Evidence",
"display" : "Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-4-BG001",
"type" : "Evidence",
"display" : "Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379"
},
{
"reference" : "#NCT03421379-BaselineMeasure-4-BG002",
"type" : "Evidence",
"display" : "Region of Enrollment for Total at baseline in NCT03421379"
}
]
}
]
}