FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Composition |
| Id | Composition-399874.json |
| FHIR Version | R6 |
No resources found
No resources found
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
| Type | Target[x] |
| Cite As | Adverse Events Report for NCT03421379 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 399874. Revised 2025-12-11. Available at: https://fevir.net/resources/Composition/399874. Computable resource at: https://fevir.net/resources/Composition/399874#json. |
Generated Narrative: EvidenceVariable #NCT03421379-AllCauseMortality
Profile: VariableDefinition
title: All-cause mortality (timeframe for NCT03421379)
status: Active
Definitions
Concept All-cause mortality handling: boolean variable
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvents
Profile: VariableDefinition
title: Serious Adverse Events (timeframe for NCT03421379)
status: Active
Definitions
Concept Serious Adverse Events handling: boolean variable
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvents
Profile: VariableDefinition
title: Other Adverse Events (timeframe for NCT03421379)
status: Active
Definitions
Concept Other Adverse Events handling: boolean variable
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG000
Profile: NonComparativeEvidence
name: NCT03421379_AllCauseMortality_EG000
title: All-cause mortality for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG000
Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvents_EG000
title: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvents_EG000
title: Other Adverse Events for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.2113
numberAffected: 15
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG001
Profile: NonComparativeEvidence
name: NCT03421379_AllCauseMortality_EG001
title: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG001
Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvents_EG001
title: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.0143
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvents_EG001
title: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379)
statistic
statisticType: Percentage
quantity: 0.1857
numberAffected: 13
SampleSizes
KnownDataCount 70
Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG000
Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvent_0_EG000
title: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Vertigo positional as serious adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG001
Profile: NonComparativeEvidence
name: NCT03421379_SeriousAdverseEvent_0_EG001
title: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Vertigo positional as serious adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvent-0
Profile: VariableDefinition
title: Vertigo positional as serious adverse event
status: Active
Definitions
Concept Vertigo positional as serious adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Serious Adverse Event, Ear and labyrinth disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_0_EG000
title: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0282
numberOfEvents: 2
numberAffected: 2
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_0_EG001
title: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-0
Profile: VariableDefinition
title: Ear pain as other adverse event
status: Active
Definitions
Concept Ear pain as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Ear and labyrinth disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_1_EG000
title: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_1_EG001
title: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-1
Profile: VariableDefinition
title: Eye pain as other adverse event
status: Active
Definitions
Concept Eye pain as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_2_EG000
title: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Eye pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_2_EG001
title: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Eye pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-2
Profile: VariableDefinition
title: Eye pruritus as other adverse event
status: Active
Definitions
Concept Eye pruritus as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_3_EG000
title: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Lacrimation increased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_3_EG001
title: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Lacrimation increased as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-3
Profile: VariableDefinition
title: Lacrimation increased as other adverse event
status: Active
Definitions
Concept Lacrimation increased as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_4_EG000
title: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_4_EG001
title: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-4
Profile: VariableDefinition
title: Diarrhoea as other adverse event
status: Active
Definitions
Concept Diarrhoea as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_5_EG000
title: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0704
numberOfEvents: 5
numberAffected: 5
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_5_EG001
title: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.1571
numberOfEvents: 11
numberAffected: 11
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-5
Profile: VariableDefinition
title: Nausea as other adverse event
status: Active
Definitions
Concept Nausea as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_6_EG000
title: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_6_EG001
title: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-6
Profile: VariableDefinition
title: Toothache as other adverse event
status: Active
Definitions
Concept Toothache as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_7_EG000
title: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0282
numberOfEvents: 2
numberAffected: 2
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_7_EG001
title: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0571
numberOfEvents: 5
numberAffected: 4
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-7
Profile: VariableDefinition
title: Vomiting as other adverse event
status: Active
Definitions
Concept Vomiting as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_8_EG000
title: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Feeling abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_8_EG001
title: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Feeling abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-8
Profile: VariableDefinition
title: Feeling abnormal as other adverse event
status: Active
Definitions
Concept Feeling abnormal as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_9_EG000
title: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_9_EG001
title: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-9
Profile: VariableDefinition
title: Cystitis as other adverse event
status: Active
Definitions
Concept Cystitis as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Infections and infestations
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_10_EG000
title: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Blood pressure decreased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_10_EG001
title: Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Blood pressure decreased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0286
numberOfEvents: 2
numberAffected: 2
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-10
Profile: VariableDefinition
title: Blood pressure decreased as other adverse event
status: Active
Definitions
Concept Blood pressure decreased as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_11_EG000
title: Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Blood pressure increased as other adverse event
statistic
statisticType: Percentage
quantity: 0.0563
numberOfEvents: 4
numberAffected: 4
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_11_EG001
title: Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Blood pressure increased as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-11
Profile: VariableDefinition
title: Blood pressure increased as other adverse event
status: Active
Definitions
Concept Blood pressure increased as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_12_EG000
title: Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_12_EG001
title: Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-12
Profile: VariableDefinition
title: Back pain as other adverse event
status: Active
Definitions
Concept Back pain as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_13_EG000
title: Headache as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_13_EG001
title: Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-13
Profile: VariableDefinition
title: Headache as other adverse event
status: Active
Definitions
Concept Headache as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_14_EG000
title: Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Nasal congestion as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_14_EG001
title: Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Nasal congestion as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-14
Profile: VariableDefinition
title: Nasal congestion as other adverse event
status: Active
Definitions
Concept Nasal congestion as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_15_EG000
title: Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Nasal pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_15_EG001
title: Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Nasal pruritus as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-15
Profile: VariableDefinition
title: Nasal pruritus as other adverse event
status: Active
Definitions
Concept Nasal pruritus as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_16_EG000
title: Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Oropharyngeal pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.0141
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_16_EG001
title: Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Oropharyngeal pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-16
Profile: VariableDefinition
title: Oropharyngeal pain as other adverse event
status: Active
Definitions
Concept Oropharyngeal pain as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_17_EG000
title: Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0845
numberOfEvents: 6
numberAffected: 6
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_17_EG001
title: Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-17
Profile: VariableDefinition
title: Rhinalgia as other adverse event
status: Active
Definitions
Concept Rhinalgia as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_18_EG000
title: Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Cold sweat as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_18_EG001
title: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Cold sweat as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-18
Profile: VariableDefinition
title: Cold sweat as other adverse event
status: Active
Definitions
Concept Cold sweat as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Skin and subcutaneous tissue disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_19_EG000
title: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_19_EG001
title: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-19
Profile: VariableDefinition
title: Hot flush as other adverse event
status: Active
Definitions
Concept Hot flush as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_20_EG000
title: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Hypertension as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_20_EG001
title: Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Hypertension as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-20
Profile: VariableDefinition
title: Hypertension as other adverse event
status: Active
Definitions
Concept Hypertension as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG000
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_21_EG000
title: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379
status: Active
variableDefinition
description:
Glucagon Nasal Powder
variableRole: Population
observed: A single dose of 3 mg glucagon nasal powder was administered intranasally
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Peripheral coldness as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
KnownDataCount 71
Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG001
Profile: NonComparativeEvidence
name: NCT03421379_OtherAdverseEvent_21_EG001
title: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status: Active
variableDefinition
description:
Glucagon Hydrochloride Solution
variableRole: Population
observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variableDefinition
note:
All randomized participants who received at least one dose of study drug.
variableRole: Outcome
observed: EvidenceVariable Peripheral coldness as other adverse event
statistic
statisticType: Percentage
quantity: 0.0143
numberOfEvents: 1
numberAffected: 1
SampleSizes
KnownDataCount 70
Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-21
Profile: VariableDefinition
title: Peripheral coldness as other adverse event
status: Active
Definitions
Concept Peripheral coldness as other adverse event definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 18.1
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
Text From Baseline to End of Follow-up (Up to 2 Months)
{
"resourceType": "Composition",
"id": "399874",
"meta": {
"versionId": "5",
"lastUpdated": "2025-12-11T20:35:21.032Z",
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report"
]
},
"language": "en",
"text": {
"status": "generated",
"div": "<!-- snip (see above) -->"
},
"contained": [
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-AllCauseMortality",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "All-cause mortality (timeframe for NCT03421379)",
"status": "active",
"definition": {
"concept": {
"text": "All-cause mortality"
}
},
"handling": "boolean",
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-SeriousAdverseEvents",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Serious Adverse Events (timeframe for NCT03421379)",
"status": "active",
"definition": {
"concept": {
"text": "Serious Adverse Events"
}
},
"handling": "boolean",
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvents",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Other Adverse Events (timeframe for NCT03421379)",
"status": "active",
"definition": {
"concept": {
"text": "Other Adverse Events"
}
},
"handling": "boolean",
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-AllCauseMortality-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_AllCauseMortality_EG000",
"title": "All-cause mortality for Glucagon Nasal Powder in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Nasal Powder",
"variableRole": "population",
"observed": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-AllCauseMortality",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-SeriousAdverseEvents-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_SeriousAdverseEvents_EG000",
"title": "Serious Adverse Events for Glucagon Nasal Powder in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Nasal Powder",
"variableRole": "population",
"observed": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-SeriousAdverseEvents",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvents-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_OtherAdverseEvents_EG000",
"title": "Other Adverse Events for Glucagon Nasal Powder in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Nasal Powder",
"variableRole": "population",
"observed": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvents",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.2113
},
"numberAffected": 15,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-AllCauseMortality-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_AllCauseMortality_EG001",
"title": "All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Hydrochloride Solution",
"variableRole": "population",
"observed": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-AllCauseMortality",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-SeriousAdverseEvents-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_SeriousAdverseEvents_EG001",
"title": "Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Hydrochloride Solution",
"variableRole": "population",
"observed": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-SeriousAdverseEvents",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvents-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"name": "NCT03421379_OtherAdverseEvents_EG001",
"title": "Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Hydrochloride Solution",
"variableRole": "population",
"observed": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvents",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.1857
},
"numberAffected": 13,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-SeriousAdverseEvent-0-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-SeriousAdverseEvent-0",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-SeriousAdverseEvent-0-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-SeriousAdverseEvent-0",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-SeriousAdverseEvent-0",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Vertigo positional as serious adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Vertigo positional as serious adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Serious Adverse Event"
},
{
"text": "Ear and labyrinth disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-0-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-0",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0282
},
"numberOfEvents": 2,
"numberAffected": 2,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-0-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-0",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-0",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Ear pain as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Ear pain as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Ear and labyrinth disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-1-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-1",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-1-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-1",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-1",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Eye pain as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Eye pain as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Eye disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-2-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-2",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-2-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-2",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-2",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Eye pruritus as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Eye pruritus as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Eye disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-3-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-3",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-3-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-3",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-3",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Lacrimation increased as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Lacrimation increased as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"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",
"title": "Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379",
"status": "active",
"variableDefinition": [
{
"description": "Glucagon Nasal Powder",
"variableRole": "population",
"observed": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-4",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-4-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-4",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-4",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Diarrhoea as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Diarrhoea as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Gastrointestinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-5-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-5",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0704
},
"numberOfEvents": 5,
"numberAffected": 5,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-5-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-5",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.1571
},
"numberOfEvents": 11,
"numberAffected": 11,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-5",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Nausea as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Nausea as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Gastrointestinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-6-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-6",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-6-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-6",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-6",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Toothache as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Toothache as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Gastrointestinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-7-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-7",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0282
},
"numberOfEvents": 2,
"numberAffected": 2,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-7-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-7",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0571
},
"numberOfEvents": 5,
"numberAffected": 4,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-7",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Vomiting as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Vomiting as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Gastrointestinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-8-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-8",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-8-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-8",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-8",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Feeling abnormal as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Feeling abnormal as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "General disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-9-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-9",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-9-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-9",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-9",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Cystitis as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Cystitis as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"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",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-10",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-10-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-10",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0286
},
"numberOfEvents": 2,
"numberAffected": 2,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-10",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Blood pressure decreased as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Blood pressure decreased as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Investigations"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-11-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-11",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0563
},
"numberOfEvents": 4,
"numberAffected": 4,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-11-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-11",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-11",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Blood pressure increased as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Blood pressure increased as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Investigations"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-12-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-12",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-12-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-12",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-12",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Back pain as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Back pain as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Musculoskeletal and connective tissue disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-13-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-13",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-13-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-13",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-13",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Headache as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Headache as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Nervous system disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-14-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-14",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-14-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-14",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-14",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Nasal congestion as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Nasal congestion as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Respiratory, thoracic and mediastinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-15-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-15",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-15-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-15",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-15",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Nasal pruritus as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Nasal pruritus as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Respiratory, thoracic and mediastinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-16-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-16",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0141
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-16-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-16",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-16",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Oropharyngeal pain as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Oropharyngeal pain as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Respiratory, thoracic and mediastinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-17-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-17",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0845
},
"numberOfEvents": 6,
"numberAffected": 6,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-17-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-17",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-17",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Rhinalgia as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Rhinalgia as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Respiratory, thoracic and mediastinal disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-18-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-18",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-18-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-18",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-18",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Cold sweat as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Cold sweat as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Skin and subcutaneous tissue disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-19-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-19",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-19-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-19",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-19",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Hot flush as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Hot flush as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Vascular disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-20-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-20",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-20-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-20",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-20",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Hypertension as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Hypertension as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Vascular disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-21-EG000",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 3 mg glucagon nasal powder was administered intranasally"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-21",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0
},
"numberOfEvents": 0,
"numberAffected": 0,
"sampleSize": {
"knownDataCount": 71
}
}
]
},
{
"resourceType": "Evidence",
"id": "NCT03421379-OtherAdverseEvent-21-EG001",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence"
]
},
"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": {
"display": "A single dose of 1 mg glucagon hydrochloride solution was administered IM"
}
},
{
"note": [
{
"text": "All randomized participants who received at least one dose of study drug."
}
],
"variableRole": "outcome",
"observed": {
"reference": "#NCT03421379-OtherAdverseEvent-21",
"type": "EvidenceVariable"
}
}
],
"statistic": [
{
"statisticType": {
"text": "Percentage"
},
"quantity": {
"value": 0.0143
},
"numberOfEvents": 1,
"numberAffected": 1,
"sampleSize": {
"knownDataCount": 70
}
}
]
},
{
"resourceType": "EvidenceVariable",
"id": "NCT03421379-OtherAdverseEvent-21",
"meta": {
"profile": [
"http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition"
]
},
"title": "Peripheral coldness as other adverse event",
"status": "active",
"definition": {
"concept": {
"text": "Peripheral coldness as other adverse event"
}
},
"definitionModifier": [
{
"code": {
"text": "Adverse event assessment type"
},
"valueCodeableConcept": {
"coding": [
{
"system": "http://hl7.org/fhir/definition-method",
"code": "systematic-assessment",
"display": "Systematic Assessment"
}
]
}
},
{
"code": {
"text": "Source Vocabulary for Adverse Event Definition"
},
"valueCodeableConcept": {
"text": "MedDRA 18.1"
}
}
],
"handling": "boolean",
"classifier": [
{
"text": "Other Adverse Event"
},
{
"text": "Vascular disorders"
}
],
"timing": {
"text": "From Baseline to End of Follow-up (Up to 2 Months)"
}
}
],
"url": "https://fevir.net/resources/Composition/399874",
"identifier": [
{
"type": {
"coding": [
{
"system": "http://terminology.hl7.org/CodeSystem/v2-0203",
"code": "ACSN",
"display": "Accession ID"
}
],
"text": "FEvIR Object Identifier"
},
"system": "https://fevir.net/FOI",
"value": "399874",
"assigner": {
"display": "Computable Publishing LLC"
}
},
{
"type": {
"text": "FEvIR Linking Identifier"
},
"system": "https://fevir.net/FLI",
"value": "NCT03421379-adverse-events-report",
"assigner": {
"display": "Computable Publishing LLC"
}
}
],
"status": "final",
"type": {
"coding": [
{
"system": "https://fevir.net/resources/CodeSystem/179423",
"code": "OutcomeMeasureReport",
"display": "OutcomeMeasureReport"
}
],
"text": "Outcome Measure Report"
},
"date": "2025-12-11T20:35:21.032Z",
"author": [
{
"display": "[No author listed.]"
}
],
"title": "Adverse Events Report for NCT03421379",
"custodian": {
"reference": "Organization/118079",
"type": "Organization",
"display": "Computable Publishing LLC"
},
"relatesTo": [
{
"type": "cite-as",
"targetMarkdown": "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."
}
],
"section": [
{
"title": "Events Frequency Threshold",
"code": {
"text": "EventsFrequencyThreshold"
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">0%</div>"
}
},
{
"title": "Events Time Frame",
"code": {
"text": "EventsTimeFrame"
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">From Baseline to End of Follow-up (Up to 2 Months)</div>"
}
},
{
"title": "Events Description",
"code": {
"text": "EventsDescription"
},
"text": {
"status": "generated",
"div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">All randomized participants who received at least one dose of study drug.</div>"
}
},
{
"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"
}
]
}
]
}
]
}