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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-399874.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Composition 399874

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

-TypeTarget[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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

Source1

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  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "EvidenceVariable",
      "id": "NCT03421379-AllCauseMortality",
      "meta": {
        "profile": [
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      },
      "title": "All-cause mortality (timeframe for NCT03421379)",
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      "definition": {
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      }
    },
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      "meta": {
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        ]
      },
      "title": "Serious Adverse Events (timeframe for NCT03421379)",
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      "definition": {
        "concept": {
          "text": "Serious Adverse Events"
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      },
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      "timing": {
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    },
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      "meta": {
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      },
      "title": "Other Adverse Events (timeframe for NCT03421379)",
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          "text": "Other Adverse Events"
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      "handling": "boolean",
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    {
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      },
      "name": "NCT03421379_AllCauseMortality_EG000",
      "title": "All-cause mortality for Glucagon Nasal Powder in NCT03421379",
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      "variableDefinition": [
        {
          "description": "Glucagon Nasal Powder",
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        },
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      ],
      "statistic": [
        {
          "statisticType": {
            "text": "Percentage"
          },
          "quantity": {
            "value": 0
          },
          "numberAffected": 0,
          "sampleSize": {
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        }
      ]
    },
    {
      "resourceType": "Evidence",
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      "meta": {
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        ]
      },
      "name": "NCT03421379_SeriousAdverseEvents_EG000",
      "title": "Serious Adverse Events for Glucagon Nasal Powder in NCT03421379",
      "status": "active",
      "variableDefinition": [
        {
          "description": "Glucagon Nasal Powder",
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            {
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      ],
      "statistic": [
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          "statisticType": {
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          },
          "quantity": {
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          },
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        }
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    {
      "resourceType": "Evidence",
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      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
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              "text": "All randomized participants who received at least one dose of study drug."
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      "resourceType": "Evidence",
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        "profile": [
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          "description": "Glucagon Hydrochloride Solution",
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            {
              "text": "All randomized participants who received at least one dose of study drug."
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          "statisticType": {
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      "resourceType": "Evidence",
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        "profile": [
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              "text": "All randomized participants who received at least one dose of study drug."
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        "profile": [
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      },
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        {
          "text": "Eye disorders"
        }
      ],
      "timing": {
        "text": "From Baseline to End of Follow-up (Up to 2 Months)"
      }
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03421379-OtherAdverseEvent-4-EG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
        ]
      },
      "name": "NCT03421379_OtherAdverseEvent_4_EG000",
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        {
          "description": "Glucagon Nasal Powder",
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        },
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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          ],
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        }
      ],
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        {
          "statisticType": {
            "text": "Percentage"
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    },
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
      "name": "NCT03421379_OtherAdverseEvent_4_EG001",
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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        }
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      "statistic": [
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          "statisticType": {
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    },
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      "resourceType": "EvidenceVariable",
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        "profile": [
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      "resourceType": "Evidence",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      "name": "NCT03421379_OtherAdverseEvent_5_EG000",
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            {
              "text": "All randomized participants who received at least one dose of study drug."
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      "name": "NCT03421379_OtherAdverseEvent_5_EG001",
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            {
              "text": "All randomized participants who received at least one dose of study drug."
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          "text": "Gastrointestinal disorders"
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      "resourceType": "Evidence",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
      "name": "NCT03421379_OtherAdverseEvent_6_EG000",
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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        }
      ]
    },
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      "resourceType": "Evidence",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      "name": "NCT03421379_OtherAdverseEvent_6_EG001",
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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          "statisticType": {
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    },
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      "resourceType": "EvidenceVariable",
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      "meta": {
        "profile": [
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      "resourceType": "Evidence",
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        "profile": [
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      "name": "NCT03421379_OtherAdverseEvent_7_EG000",
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          "description": "Glucagon Nasal Powder",
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            "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
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        },
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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            "knownDataCount": 71
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        }
      ]
    },
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      "resourceType": "Evidence",
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      "name": "NCT03421379_OtherAdverseEvent_7_EG001",
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            {
              "text": "All randomized participants who received at least one dose of study drug."
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      "meta": {
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      "resourceType": "Evidence",
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        "profile": [
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        {
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        },
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          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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        }
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        }
      ]
    },
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      "resourceType": "Evidence",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      "name": "NCT03421379_OtherAdverseEvent_8_EG001",
      "title": "Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379",
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          "description": "Glucagon Hydrochloride Solution",
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            "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
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        },
        {
          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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            "text": "Percentage"
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      "resourceType": "EvidenceVariable",
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      "meta": {
        "profile": [
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      },
      "title": "Feeling abnormal as other adverse event",
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          "text": "Feeling abnormal as other adverse event"
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                "system": "http://hl7.org/fhir/definition-method",
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            "text": "Source Vocabulary for Adverse Event Definition"
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          "text": "Other Adverse Event"
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        {
          "text": "General disorders"
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      ],
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        "text": "From Baseline to End of Follow-up (Up to 2 Months)"
      }
    },
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      "resourceType": "Evidence",
      "id": "NCT03421379-OtherAdverseEvent-9-EG000",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
      "name": "NCT03421379_OtherAdverseEvent_9_EG000",
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          "description": "Glucagon Nasal Powder",
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            "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
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        },
        {
          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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          "statisticType": {
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          "quantity": {
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        }
      ]
    },
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      "resourceType": "Evidence",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      "name": "NCT03421379_OtherAdverseEvent_9_EG001",
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            "display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
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        {
          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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        }
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      "resourceType": "EvidenceVariable",
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      "meta": {
        "profile": [
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      },
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        "concept": {
          "text": "Cystitis as other adverse event"
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      },
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      ],
      "handling": "boolean",
      "classifier": [
        {
          "text": "Other Adverse Event"
        },
        {
          "text": "Infections and infestations"
        }
      ],
      "timing": {
        "text": "From Baseline to End of Follow-up (Up to 2 Months)"
      }
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03421379-OtherAdverseEvent-10-EG000",
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        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
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      },
      "name": "NCT03421379_OtherAdverseEvent_10_EG000",
      "title": "Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379",
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        {
          "description": "Glucagon Nasal Powder",
          "variableRole": "population",
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            "display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
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        },
        {
          "note": [
            {
              "text": "All randomized participants who received at least one dose of study drug."
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    },
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  "date": "2025-12-11T20:35:21.032Z",
  "author": [
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  ],
  "title": "Adverse Events Report for NCT03421379",
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    },
    {
      "title": "Glucagon Nasal Powder",
      "code": {
        "text": "EG000 Glucagon Nasal Powder"
      },
      "section": [
        {
          "title": "Event Group Description",
          "code": {
            "text": "EventGroupDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 3 mg glucagon nasal powder was administered intranasally</div>"
          }
        }
      ]
    },
    {
      "title": "Glucagon Hydrochloride Solution",
      "code": {
        "text": "EG001 Glucagon Hydrochloride Solution"
      },
      "section": [
        {
          "title": "Event Group Description",
          "code": {
            "text": "EventGroupDescription"
          },
          "text": {
            "status": "generated",
            "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">A single dose of 1 mg glucagon hydrochloride solution was administered IM</div>"
          }
        }
      ]
    },
    {
      "title": "Total Mortality",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Total Mortality"
      },
      "focus": {
        "reference": "#NCT03421379-AllCauseMortality",
        "type": "EvidenceVariable",
        "display": "All-cause mortality (timeframe for NCT03421379)"
      },
      "entry": [
        {
          "reference": "#NCT03421379-AllCauseMortality-EG000",
          "type": "Evidence",
          "display": "All-cause mortality for Glucagon Nasal Powder in NCT03421379"
        },
        {
          "reference": "#NCT03421379-AllCauseMortality-EG001",
          "type": "Evidence",
          "display": "All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379"
        }
      ]
    },
    {
      "title": "Total Serious Events",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Total Serious Events"
      },
      "focus": {
        "reference": "#NCT03421379-SeriousAdverseEvents",
        "type": "EvidenceVariable",
        "display": "Serious Adverse Events (timeframe for NCT03421379)"
      },
      "entry": [
        {
          "reference": "#NCT03421379-SeriousAdverseEvents-EG000",
          "type": "Evidence",
          "display": "Serious Adverse Events for Glucagon Nasal Powder in NCT03421379"
        },
        {
          "reference": "#NCT03421379-SeriousAdverseEvents-EG001",
          "type": "Evidence",
          "display": "Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379"
        }
      ]
    },
    {
      "title": "Total Other Events",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Total Other Events"
      },
      "focus": {
        "reference": "#NCT03421379-OtherAdverseEvents",
        "type": "EvidenceVariable",
        "display": "Other Adverse Events (timeframe for NCT03421379)"
      },
      "entry": [
        {
          "reference": "#NCT03421379-OtherAdverseEvents-EG000",
          "type": "Evidence",
          "display": "Other Adverse Events for Glucagon Nasal Powder in NCT03421379"
        },
        {
          "reference": "#NCT03421379-OtherAdverseEvents-EG001",
          "type": "Evidence",
          "display": "Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379"
        }
      ]
    },
    {
      "title": "Serious Event List",
      "code": {
        "text": "SeriousEventList"
      },
      "section": [
        {
          "title": "Vertigo positional",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-SeriousAdverseEvent-0",
            "type": "EvidenceVariable",
            "display": "Vertigo positional as serious adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-SeriousAdverseEvent-0-EG000",
              "type": "Evidence",
              "display": "Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-SeriousAdverseEvent-0-EG001",
              "type": "Evidence",
              "display": "Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        }
      ]
    },
    {
      "title": "Other Event List",
      "code": {
        "text": "OtherEventList"
      },
      "section": [
        {
          "title": "Ear pain",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-0",
            "type": "EvidenceVariable",
            "display": "Ear pain as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-0-EG000",
              "type": "Evidence",
              "display": "Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-0-EG001",
              "type": "Evidence",
              "display": "Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Eye pain",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-1",
            "type": "EvidenceVariable",
            "display": "Eye pain as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-1-EG000",
              "type": "Evidence",
              "display": "Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-1-EG001",
              "type": "Evidence",
              "display": "Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Eye pruritus",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-2",
            "type": "EvidenceVariable",
            "display": "Eye pruritus as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-2-EG000",
              "type": "Evidence",
              "display": "Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-2-EG001",
              "type": "Evidence",
              "display": "Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Lacrimation increased",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-3",
            "type": "EvidenceVariable",
            "display": "Lacrimation increased as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-3-EG000",
              "type": "Evidence",
              "display": "Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-3-EG001",
              "type": "Evidence",
              "display": "Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Diarrhoea",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-4",
            "type": "EvidenceVariable",
            "display": "Diarrhoea as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-4-EG000",
              "type": "Evidence",
              "display": "Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-4-EG001",
              "type": "Evidence",
              "display": "Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Nausea",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-5",
            "type": "EvidenceVariable",
            "display": "Nausea as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-5-EG000",
              "type": "Evidence",
              "display": "Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-5-EG001",
              "type": "Evidence",
              "display": "Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Toothache",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-6",
            "type": "EvidenceVariable",
            "display": "Toothache as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-6-EG000",
              "type": "Evidence",
              "display": "Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-6-EG001",
              "type": "Evidence",
              "display": "Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Vomiting",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-7",
            "type": "EvidenceVariable",
            "display": "Vomiting as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-7-EG000",
              "type": "Evidence",
              "display": "Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-7-EG001",
              "type": "Evidence",
              "display": "Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Feeling abnormal",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-8",
            "type": "EvidenceVariable",
            "display": "Feeling abnormal as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-8-EG000",
              "type": "Evidence",
              "display": "Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-8-EG001",
              "type": "Evidence",
              "display": "Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Cystitis",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-9",
            "type": "EvidenceVariable",
            "display": "Cystitis as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-9-EG000",
              "type": "Evidence",
              "display": "Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-9-EG001",
              "type": "Evidence",
              "display": "Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Blood pressure decreased",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-10",
            "type": "EvidenceVariable",
            "display": "Blood pressure decreased as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-10-EG000",
              "type": "Evidence",
              "display": "Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-10-EG001",
              "type": "Evidence",
              "display": "Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Blood pressure increased",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-11",
            "type": "EvidenceVariable",
            "display": "Blood pressure increased as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-11-EG000",
              "type": "Evidence",
              "display": "Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-11-EG001",
              "type": "Evidence",
              "display": "Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Back pain",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-12",
            "type": "EvidenceVariable",
            "display": "Back pain as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-12-EG000",
              "type": "Evidence",
              "display": "Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-12-EG001",
              "type": "Evidence",
              "display": "Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Headache",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-13",
            "type": "EvidenceVariable",
            "display": "Headache as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-13-EG000",
              "type": "Evidence",
              "display": "Headache as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-13-EG001",
              "type": "Evidence",
              "display": "Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Nasal congestion",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-14",
            "type": "EvidenceVariable",
            "display": "Nasal congestion as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-14-EG000",
              "type": "Evidence",
              "display": "Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-14-EG001",
              "type": "Evidence",
              "display": "Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Nasal pruritus",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-15",
            "type": "EvidenceVariable",
            "display": "Nasal pruritus as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-15-EG000",
              "type": "Evidence",
              "display": "Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-15-EG001",
              "type": "Evidence",
              "display": "Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Oropharyngeal pain",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-16",
            "type": "EvidenceVariable",
            "display": "Oropharyngeal pain as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-16-EG000",
              "type": "Evidence",
              "display": "Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-16-EG001",
              "type": "Evidence",
              "display": "Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Rhinalgia",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-17",
            "type": "EvidenceVariable",
            "display": "Rhinalgia as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-17-EG000",
              "type": "Evidence",
              "display": "Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-17-EG001",
              "type": "Evidence",
              "display": "Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Cold sweat",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-18",
            "type": "EvidenceVariable",
            "display": "Cold sweat as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-18-EG000",
              "type": "Evidence",
              "display": "Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-18-EG001",
              "type": "Evidence",
              "display": "Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Hot flush",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-19",
            "type": "EvidenceVariable",
            "display": "Hot flush as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-19-EG000",
              "type": "Evidence",
              "display": "Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-19-EG001",
              "type": "Evidence",
              "display": "Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Hypertension",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-20",
            "type": "EvidenceVariable",
            "display": "Hypertension as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-20-EG000",
              "type": "Evidence",
              "display": "Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-20-EG001",
              "type": "Evidence",
              "display": "Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        },
        {
          "title": "Peripheral coldness",
          "code": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "results",
                "display": "Results"
              }
            ]
          },
          "focus": {
            "reference": "#NCT03421379-OtherAdverseEvent-21",
            "type": "EvidenceVariable",
            "display": "Peripheral coldness as other adverse event"
          },
          "entry": [
            {
              "reference": "#NCT03421379-OtherAdverseEvent-21-EG000",
              "type": "Evidence",
              "display": "Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379"
            },
            {
              "reference": "#NCT03421379-OtherAdverseEvent-21-EG001",
              "type": "Evidence",
              "display": "Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379"
            }
          ]
        }
      ]
    }
  ]
}