Adverse Events 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: Adverse Events Report for NCT03421379

version: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en

Profile: OutcomeMeasureReport

url: https://fevir.net/resources/Composition/399874

identifier: FEvIR Object Identifier/399874, FEvIR Linking Identifier/NCT03421379-adverse-events-report

status: Final

type: Outcome Measure Report

date: 2025-12-11 20:35:21+0000

author: [No author listed.]

title: Adverse Events Report for NCT03421379

custodian: Computable Publishing LLC

RelatesTos

Type

Target[x]

Cite As

Adverse Events Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399874. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399874. Computable resource at: https://fevir.net/resources/Composition/399874#json.

Generated Narrative: EvidenceVariable #NCT03421379-AllCauseMortality

Profile: VariableDefinition
title: All-cause mortality (timeframe for NCT03421379)
status: Active
Definitions
- Concept
* All-cause mortality
handling: boolean variable
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvents

Profile: VariableDefinition
title: Serious Adverse Events (timeframe for NCT03421379)
status: Active
Definitions
- Concept
* Serious Adverse Events
handling: boolean variable
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvents

Profile: VariableDefinition
title: Other Adverse Events (timeframe for NCT03421379)
status: Active
Definitions
- Concept
* Other Adverse Events
handling: boolean variable
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG000

Profile: NonComparativeEvidence
name: NCT03421379_AllCauseMortality_EG000
title: All-cause mortality for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG000

Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvents_EG000
title: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvents_EG000
title: Other Adverse Events for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.2113
numberAffected: 15
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG001

Profile: NonComparativeEvidence
name: NCT03421379_AllCauseMortality_EG001
title: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG001

Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvents_EG001
title: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.0143
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvents_EG001
title: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.1857
numberAffected: 13
SampleSizes
- KnownDataCount
* 70

Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG000

Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvent_0_EG000
title: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Vertigo positional as serious adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG001

Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvent_0_EG001
title: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Vertigo positional as serious adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvent-0

Profile: VariableDefinition
title: Vertigo positional as serious adverse event
status: Active
Definitions
- Concept
* Vertigo positional as serious adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Serious Adverse Event, Ear and labyrinth disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_0_EG000
title: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Ear pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.0282
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_0_EG001
title: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Ear pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-0

Profile: VariableDefinition
title: Ear pain as other adverse event
status: Active
Definitions
- Concept
* Ear pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Ear and labyrinth disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_1_EG000
title: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Eye pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_1_EG001
title: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Eye pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-1

Profile: VariableDefinition
title: Eye pain as other adverse event
status: Active
Definitions
- Concept
* Eye pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_2_EG000
title: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Eye pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_2_EG001
title: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Eye pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-2

Profile: VariableDefinition
title: Eye pruritus as other adverse event
status: Active
Definitions
- Concept
* Eye pruritus as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_3_EG000
title: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Lacrimation increased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_3_EG001
title: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Lacrimation increased as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-3

Profile: VariableDefinition
title: Lacrimation increased as other adverse event
status: Active
Definitions
- Concept
* Lacrimation increased as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_4_EG000
title: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Diarrhoea as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_4_EG001
title: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Diarrhoea as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-4

Profile: VariableDefinition
title: Diarrhoea as other adverse event
status: Active
Definitions
- Concept
* Diarrhoea as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_5_EG000
title: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nausea as other adverse event
statistic
statisticType: Percentage
quantity: 0.0704
numberOfEvents: 5
numberAffected: 5
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_5_EG001
title: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nausea as other adverse event
statistic
statisticType: Percentage
quantity: 0.1571
numberOfEvents: 11
numberAffected: 11
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-5

Profile: VariableDefinition
title: Nausea as other adverse event
status: Active
Definitions
- Concept
* Nausea as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_6_EG000
title: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Toothache as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_6_EG001
title: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Toothache as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-6

Profile: VariableDefinition
title: Toothache as other adverse event
status: Active
Definitions
- Concept
* Toothache as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_7_EG000
title: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Vomiting as other adverse event
statistic
statisticType: Percentage
quantity: 0.0282
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_7_EG001
title: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Vomiting as other adverse event
statistic
statisticType: Percentage
quantity: 0.0571
numberOfEvents: 5
numberAffected: 4
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-7

Profile: VariableDefinition
title: Vomiting as other adverse event
status: Active
Definitions
- Concept
* Vomiting as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_8_EG000
title: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Feeling abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_8_EG001
title: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Feeling abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-8

Profile: VariableDefinition
title: Feeling abnormal as other adverse event
status: Active
Definitions
- Concept
* Feeling abnormal as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_9_EG000
title: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Cystitis as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_9_EG001
title: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Cystitis as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-9

Profile: VariableDefinition
title: Cystitis as other adverse event
status: Active
Definitions
- Concept
* Cystitis as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Infections and infestations
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_10_EG000
title: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Blood pressure decreased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_10_EG001
title: Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Blood pressure decreased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0286
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-10

Profile: VariableDefinition
title: Blood pressure decreased as other adverse event
status: Active
Definitions
- Concept
* Blood pressure decreased as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_11_EG000
title: Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Blood pressure increased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0563
numberOfEvents: 4
numberAffected: 4
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_11_EG001
title: Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Blood pressure increased as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-11

Profile: VariableDefinition
title: Blood pressure increased as other adverse event
status: Active
Definitions
- Concept
* Blood pressure increased as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_12_EG000
title: Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Back pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_12_EG001
title: Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Back pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-12

Profile: VariableDefinition
title: Back pain as other adverse event
status: Active
Definitions
- Concept
* Back pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_13_EG000
title: Headache as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Headache as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_13_EG001
title: Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Headache as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-13

Profile: VariableDefinition
title: Headache as other adverse event
status: Active
Definitions
- Concept
* Headache as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_14_EG000
title: Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nasal congestion as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_14_EG001
title: Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nasal congestion as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-14

Profile: VariableDefinition
title: Nasal congestion as other adverse event
status: Active
Definitions
- Concept
* Nasal congestion as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_15_EG000
title: Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nasal pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_15_EG001
title: Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Nasal pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-15

Profile: VariableDefinition
title: Nasal pruritus as other adverse event
status: Active
Definitions
- Concept
* Nasal pruritus as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_16_EG000
title: Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Oropharyngeal pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_16_EG001
title: Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Oropharyngeal pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-16

Profile: VariableDefinition
title: Oropharyngeal pain as other adverse event
status: Active
Definitions
- Concept
* Oropharyngeal pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_17_EG000
title: Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Rhinalgia as other adverse event
statistic
statisticType: Percentage
quantity: 0.0845
numberOfEvents: 6
numberAffected: 6
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_17_EG001
title: Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Rhinalgia as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-17

Profile: VariableDefinition
title: Rhinalgia as other adverse event
status: Active
Definitions
- Concept
* Rhinalgia as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_18_EG000
title: Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Cold sweat as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_18_EG001
title: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Cold sweat as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-18

Profile: VariableDefinition
title: Cold sweat as other adverse event
status: Active
Definitions
- Concept
* Cold sweat as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Skin and subcutaneous tissue disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_19_EG000
title: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Hot flush as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_19_EG001
title: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Hot flush as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-19

Profile: VariableDefinition
title: Hot flush as other adverse event
status: Active
Definitions
- Concept
* Hot flush as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_20_EG000
title: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Hypertension as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_20_EG001
title: Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Hypertension as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-20

Profile: VariableDefinition
title: Hypertension as other adverse event
status: Active
Definitions
- Concept
* Hypertension as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG000

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_21_EG000
title: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder

variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Peripheral coldness as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 71

Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG001

Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_21_EG001
title: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution

variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.

variableRole: Outcome
observed: EvidenceVariable Peripheral coldness as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 70

Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-21

Profile: VariableDefinition
title: Peripheral coldness as other adverse event
status: Active
Definitions
- Concept
* Peripheral coldness as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
- Text
* From Baseline to End of Follow-up (Up to 2 Months)