Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
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: evidence-variable-handling-not-specified
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: evidence-variable-handling-not-specified
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: evidence-variable-handling-not-specified
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: evidence-variable-handling-not-specified
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: evidence-variable-handling-not-specified
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
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-01-07
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