FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Composition |
| Id | Composition-399872.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Composition 399872
version: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en
Profile: BaselineMeasureReport
url: https://fevir.net/resources/Composition/399872
identifier: FEvIR Object Identifier/399872, FEvIR Linking Identifier/NCT03421379-baseline-measure-report
status: Final
type: Baseline Measure Report
date: 2025-12-11 20:35:21+0000
author: [No author listed.]
title: Baseline Characteristics Report for NCT03421379
custodian: Computable Publishing LLC
| Type | Target[x] |
| Cite As | 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. |
Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-0
Profile: VariableDefinition
EvidenceVariableHandlingDetail: Evidence variable handling not specified
title: Age, Continuous
status: Active
Definitions
Concept Age, Continuous handling: extension
classifier: Baseline Measure
Timings
Offset[x] No display for Duration (value: 0)
Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-1
Profile: VariableDefinition
EvidenceVariableHandlingDetail: Evidence variable handling not specified
title: Sex: Female, Male
status: Active
Definitions
Concept Sex: Female, Male handling: extension
category
name: Female
category
name: Male
classifier: Baseline Measure
Timings
Offset[x] No display for Duration (value: 0)
Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-2
Profile: VariableDefinition
EvidenceVariableHandlingDetail: Evidence variable handling not specified
title: Ethnicity (NIH/OMB)
status: Active
Definitions
Concept Ethnicity (NIH/OMB) handling: extension
category
name: Hispanic or Latino
category
name: Not Hispanic or Latino
category
name: Unknown or Not Reported
classifier: Baseline Measure
Timings
Offset[x] No display for Duration (value: 0)
Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-3
Profile: VariableDefinition
EvidenceVariableHandlingDetail: Evidence variable handling not specified
title: Race (NIH/OMB)
status: Active
Definitions
Concept Race (NIH/OMB) handling: extension
category
name: American Indian or Alaska Native
category
name: Asian
category
name: Native Hawaiian or Other Pacific Islander
category
name: Black or African American
category
name: White
category
name: More than one race
category
name: Unknown or Not Reported
classifier: Baseline Measure
Timings
Offset[x] No display for Duration (value: 0)
Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-4
Profile: VariableDefinition
EvidenceVariableHandlingDetail: Evidence variable handling not specified
title: Region of Enrollment
status: Active
Definitions
Concept Region of Enrollment handling: extension
Categories
Name Japan classifier: Baseline Measure
Timings
Offset[x] No display for Duration (value: 0)
Generated Narrative: Group #BG000
Profile: ExposureGroup
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: Participants
quantity: 33
Characteristics
Code Value[x] Exclude Research Study from which this is a baseline group NCT03421379 false
Generated Narrative: Group #BG001
Profile: ExposureGroup
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: Participants
quantity: 39
Characteristics
Code Value[x] Exclude Research Study from which this is a baseline group NCT03421379 false
Generated Narrative: Group #BG002
Profile: ExposureGroup
name: Total
description:
Total of all reporting groups
type: Person
membership: Enumerated
code: Participants
quantity: 72
Characteristics
Code Value[x] Exclude Research Study from which this is a baseline group NCT03421379 false
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG000
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_0_BG000
title: Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution
variableDefinition
variableRole: Outcome
observed: Age, Continuous
statistic
statisticType: mean
quantity: 41.7 years
SampleSizes
KnownDataCount 33 AttributeEstimates
Type Quantity Standard Deviation 11.6 years
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG001
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_0_BG001
title: Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder
variableDefinition
variableRole: Outcome
observed: Age, Continuous
statistic
statisticType: mean
quantity: 57.5 years
SampleSizes
KnownDataCount 39 AttributeEstimates
Type Quantity Standard Deviation 9.2 years
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-0-BG002
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_0_BG002
title: Age, Continuous for Total at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Total
variableDefinition
variableRole: Outcome
observed: Age, Continuous
statistic
statisticType: mean
quantity: 50.2 years
SampleSizes
KnownDataCount 72 AttributeEstimates
Type Quantity Standard Deviation 13 years
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG000
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_1_BG000
title: Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution
variableDefinition
variableRole: Outcome
observed: Sex: Female, Male
statistic
statisticType: Count of Participants
category: Female
quantity: 13 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Male
quantity: 20 Participants
SampleSizes
KnownDataCount 33
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG001
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_1_BG001
title: Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder
variableDefinition
variableRole: Outcome
observed: Sex: Female, Male
statistic
statisticType: Count of Participants
category: Female
quantity: 9 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Male
quantity: 30 Participants
SampleSizes
KnownDataCount 39
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-1-BG002
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_1_BG002
title: Sex: Female, Male for Total at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Total
variableDefinition
variableRole: Outcome
observed: Sex: Female, Male
statistic
statisticType: Count of Participants
category: Female
quantity: 22 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Male
quantity: 50 Participants
SampleSizes
KnownDataCount 72
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG000
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_2_BG000
title: Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution
variableDefinition
variableRole: Outcome
observed: Ethnicity (NIH/OMB)
statistic
statisticType: Count of Participants
category: Hispanic or Latino
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Not Hispanic or Latino
quantity: 33 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 33
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG001
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_2_BG001
title: Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder
variableDefinition
variableRole: Outcome
observed: Ethnicity (NIH/OMB)
statistic
statisticType: Count of Participants
category: Hispanic or Latino
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Not Hispanic or Latino
quantity: 39 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 39
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-2-BG002
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_2_BG002
title: Ethnicity (NIH/OMB) for Total at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Total
variableDefinition
variableRole: Outcome
observed: Ethnicity (NIH/OMB)
statistic
statisticType: Count of Participants
category: Hispanic or Latino
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Not Hispanic or Latino
quantity: 72 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 72
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG000
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_3_BG000
title: Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution
variableDefinition
variableRole: Outcome
observed: Race (NIH/OMB)
statistic
statisticType: Count of Participants
category: American Indian or Alaska Native
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Asian
quantity: 33 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Native Hawaiian or Other Pacific Islander
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Black or African American
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: White
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: More than one race
quantity: 0 Participants
SampleSizes
KnownDataCount 33 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 33
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG001
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_3_BG001
title: Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder
variableDefinition
variableRole: Outcome
observed: Race (NIH/OMB)
statistic
statisticType: Count of Participants
category: American Indian or Alaska Native
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Asian
quantity: 39 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Native Hawaiian or Other Pacific Islander
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Black or African American
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: White
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: More than one race
quantity: 0 Participants
SampleSizes
KnownDataCount 39 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 39
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-3-BG002
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_3_BG002
title: Race (NIH/OMB) for Total at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Total
variableDefinition
variableRole: Outcome
observed: Race (NIH/OMB)
statistic
statisticType: Count of Participants
category: American Indian or Alaska Native
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Asian
quantity: 72 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Native Hawaiian or Other Pacific Islander
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Black or African American
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: White
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: More than one race
quantity: 0 Participants
SampleSizes
KnownDataCount 72 statistic
statisticType: Count of Participants
category: Unknown or Not Reported
quantity: 0 Participants
SampleSizes
KnownDataCount 72
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG000
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_4_BG000
title: Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Nasal Powder/Glucagon Hydrochloride Solution
variableDefinition
variableRole: Outcome
observed: Region of Enrollment
statistic
statisticType: Number (see protocol for details)
category: Japan
quantity: 33 participants
SampleSizes
KnownDataCount 33
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG001
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_4_BG001
title: Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Glucagon Hydrochloride Solution/Glucagon Nasal Powder
variableDefinition
variableRole: Outcome
observed: Region of Enrollment
statistic
statisticType: Number (see protocol for details)
category: Japan
quantity: 39 participants
SampleSizes
KnownDataCount 39
Generated Narrative: Evidence #NCT03421379-BaselineMeasure-4-BG002
Profile: NonComparativeEvidence
name: NCT03421379_BaselineMeasure_4_BG002
title: Region of Enrollment for Total at baseline in NCT03421379
status: Active
variableDefinition
note:
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
variableRole: Population
observed: Total
variableDefinition
variableRole: Outcome
observed: Region of Enrollment
statistic
statisticType: Number (see protocol for details)
category: Japan
quantity: 72 participants
SampleSizes
KnownDataCount 72
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"status": "active",
"variableDefinition": [
{
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],
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{
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{
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{
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"quantity": {
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"sampleSize": {
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{
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],
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"category": {
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"unit": "Participants"
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}
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{
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},
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{
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},
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{
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{
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},
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{
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{
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}
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}
],
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{
"type": {
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{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
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"text": "FEvIR Object Identifier"
},
"system": "https://fevir.net/FOI",
"value": "399872",
"assigner": {
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}
},
{
"type": {
"text": "FEvIR Linking Identifier"
},
"system": "https://fevir.net/FLI",
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"assigner": {
"display": "Computable Publishing LLC"
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}
],
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"display": "BaselineMeasureReport"
}
],
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},
"date": "2025-12-11T20:35:21.032Z",
"author": [
{
"display": "[No author listed.]"
}
],
"title": "Baseline Characteristics Report for NCT03421379",
"custodian": {
"reference": "Organization/118079",
"type": "Organization",
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},
"relatesTo": [
{
"type": "cite-as",
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],
"section": [
{
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"status": "generated",
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}
},
{
"title": "Baseline Group List",
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"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>"
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{
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{
"reference": "#BG001",
"type": "Group",
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},
{
"reference": "#BG002",
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}
]
},
{
"title": "Age, Continuous",
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}
]
},
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"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",
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"display": "Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379"
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{
"reference": "#NCT03421379-BaselineMeasure-0-BG001",
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{
"reference": "#NCT03421379-BaselineMeasure-0-BG002",
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}
]
},
{
"title": "Sex: Female, Male",
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{
"system": "https://fevir.net/resources/CodeSystem/179423",
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"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",
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"text": "BaselineMeasureCalculatePct"
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
}
}
]
},
{
"title": "Ethnicity (NIH/OMB)",
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{
"system": "https://fevir.net/resources/CodeSystem/179423",
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"display": "Results"
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]
},
"focus": {
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"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"
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}
}
]
},
{
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{
"system": "https://fevir.net/resources/CodeSystem/179423",
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]
},
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"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"
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{
"reference": "#NCT03421379-BaselineMeasure-3-BG002",
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"display": "Race (NIH/OMB) for Total at baseline in NCT03421379"
}
],
"section": [
{
"title": "Baseline Measure Calculate Percent",
"code": {
"text": "BaselineMeasureCalculatePct"
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"text": {
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">False</div>"
}
}
]
},
{
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"system": "https://fevir.net/resources/CodeSystem/179423",
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]
},
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"type": "EvidenceVariable",
"display": "Region of Enrollment"
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"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
},
"entry": [
{
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{
"reference": "#NCT03421379-BaselineMeasure-4-BG002",
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}