Baseline Characteristics Report for NCT03421379 - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot3

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

Example Composition: Baseline Characteristics Report for NCT03421379

Page standards status: Informative

version: 14; Last updated: 2026-09-24 12:35:00+0000

Profile: BaselineMeasureReport

Artifact Description:

This is an example of the BaselineMeasureReport Profile in the Evidence Based Medicine on FHIR Implementation Guide.

ArtifactPublicationStatus: Active

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: 2026-09-24 12:35:00+0000

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter

title: Baseline Characteristics Report for NCT03421379

custodian: Computable Publishing LLC

RelatesTos

Type

Target[x]

Cite As

Baseline Characteristics Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399872. Revised 2026-09-24. 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
title: Age, Continuous
status: Active
Definitions
- Concept
* Age, Continuous
handling: Evidence variable handling not specified
classifier: Baseline Measure
Timings
- Offset[x]
* 0 days (Details: UCUM coded = 'd')

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-1

Profile: VariableDefinition
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]
* 0 days (Details: UCUM coded = 'd')

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-2

Profile: VariableDefinition
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]
* 0 days (Details: UCUM coded = 'd')

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-3

Profile: VariableDefinition
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]
* 0 days (Details: UCUM coded = 'd')

Generated Narrative: EvidenceVariable #NCT03421379-BaselineMeasure-4

Profile: VariableDefinition
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]
* 0 days (Details: UCUM coded = 'd')

Exception parsing generated Narrative (see /tmp/liquid-e320c1fd-38dc-4429-ab3c-5d1ebd525006.html): Error in template: Root element is not 'div'

Exception parsing generated Narrative (see /tmp/liquid-07e674a0-e90c-44f9-a474-1b4bef284e59.html): Error in template: Root element is not 'div'

Exception parsing generated Narrative (see /tmp/liquid-609500f4-f19c-43ff-a5f8-cf1582a06333.html): Error in template: Root element is not 'div'

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