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 RelatesTos - 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
Evidence variable handling not specified
Native Hawaiian or Other Pacific Islander
Glucagon Nasal Powder/Glucagon Hydrochloride Solution
A single dose of 3 mg glucagon nasal powder was administered intranasally
Research Study from which this is a baseline group
Glucagon Hydrochloride Solution/Glucagon Nasal Powder
A single dose of 1 mg glucagon hydrochloride solution was administered IM
Age, Continuous for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
Baseline Reporting Population Description: All randomized participants who received at least one dose of study drug.
Age, Continuous for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
Age, Continuous for Total at baseline in NCT03421379
Sex: Female, Male for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
Sex: Female, Male for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
Sex: Female, Male for Total at baseline in NCT03421379
Ethnicity (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
Ethnicity (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
Ethnicity (NIH/OMB) for Total at baseline in NCT03421379
Race (NIH/OMB) for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
Race (NIH/OMB) for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
Race (NIH/OMB) for Total at baseline in NCT03421379
Region of Enrollment for Glucagon Nasal Powder/Glucagon Hydrochloride Solution at baseline in NCT03421379
Region of Enrollment for Glucagon Hydrochloride Solution/Glucagon Nasal Powder at baseline in NCT03421379
Region of Enrollment for Total at baseline in NCT03421379
Baseline Characteristics Report for NCT03421379
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.
Baseline Reporting Population Description
All randomized participants who received at least one dose of study drug.
Glucagon Nasal Powder/Glucagon Hydrochloride Solution, Glucagon Hydrochloride Solution/Glucagon Nasal Powder, Total
[No data.]
False