http://hl7.org/fhir/uv/ebm/Composition/399874
type: Composition
node role: treeRoot
id:
  v: 399874
meta:
  version id:
    v: 5
  last updated:
    v: 2025-12-11T20:35:21.032Z
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report
    l: outcome-measure-report
language:
  v: en
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Composition 399874 version: 5; Last updated: 2025-12-11 20:35:21+0000; Language: en Profile: OutcomeMeasureReport url: https://fevir.net/resources/Composition/399874 identifier: FEvIR Object Identifier/399874, FEvIR Linking Identifier/NCT03421379-adverse-events-report status: Final type: Outcome Measure Report date: 2025-12-11 20:35:21+0000 author: [No author listed.] title: Adverse Events Report for NCT03421379 custodian: Computable Publishing LLC RelatesTos - 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 …
contained: EvidenceVariable
  id:
    v: NCT03421379-AllCauseMortality
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: All-cause mortality (timeframe for NCT03421379)
  status:
    v: active
  definition:
    concept:
      text:
        v: All-cause mortality
  handling:
    v: boolean
  timing:
    text:
      v: From Baseline to End of Follow-up (Up to 2 Months)
contained: EvidenceVariable
  id:
    v: NCT03421379-SeriousAdverseEvents
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: Serious Adverse Events (timeframe for NCT03421379)
  status:
    v: active
  definition:
    concept:
      text:
        v: Serious Adverse Events
  handling:
    v: boolean
  timing:
    text:
      v: From Baseline to End of Follow-up (Up to 2 Months)
contained: EvidenceVariable
  id:
    v: NCT03421379-OtherAdverseEvents
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: Other Adverse Events (timeframe for NCT03421379)
  status:
    v: active
  definition:
    concept:
      text:
        v: Other Adverse Events
  handling:
    v: boolean
  timing:
    text:
      v: From Baseline to End of Follow-up (Up to 2 Months)
contained: Evidence
  id:
    v: NCT03421379-AllCauseMortality-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03421379_AllCauseMortality_EG000
  title:
    v: All-cause mortality for Glucagon Nasal Powder in NCT03421379
  status:
    v: active
  variable definition:
    description:
      v: Glucagon Nasal Powder
    variable role:
      v: population
    observed:
      display:
        v: A single dose of 3 mg glucagon nasal powder was administered intranasally
  variable definition:
    note:
      text:
        v: All randomized participants who received at least one dose of study drug.
    variable role:
      v: outcome
    observed:
      l: NCT03421379-AllCauseMortality
      reference:
        v: #NCT03421379-AllCauseMortality
      type:
        v: EvidenceVariable
        l: EvidenceVariable
  statistic:
    statistic type:
      text:
        v: Percentage
    quantity:
      value:
        v: 0
    number affected:
      v: 0
    sample size:
      known data count:
        v: 71
contained: Evidence
  id:
    v: NCT03421379-SeriousAdverseEvents-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03421379_SeriousAdverseEvents_EG000
  title:
    v: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379
  status:
    v: active
  variable definition:
    description:
      v: Glucagon Nasal Powder
    variable role:
      v: population
    observed:
      display:
        v: A single dose of 3 mg glucagon nasal powder was administered intranasally
  variable definition:
    note:
      text:
        v: All randomized participants who received at least one dose of study drug.
    variable role:
      v: outcome
    observed:
      l: NCT03421379-SeriousAdverseEvents
      reference:
        v: #NCT03421379-SeriousAdverseEvents
      type:
        v: EvidenceVariable
        l: EvidenceVariable
  statistic:
    statistic type:
      text:
        v: Percentage
    quantity:
      value:
        v: 0
    number affected:
      v: 0
    sample size:
      known data count:
        v: 71
contained: Evidence
  id:
    v: NCT03421379-OtherAdverseEvents-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03421379_OtherAdverseEvents_EG000
  title:
    v: Other Adverse Events for Glucagon Nasal Powder in NCT03421379
  status:
    v: active
  variable definition:
    description:
      v: Glucagon Nasal Powder
    variable role:
      v: population
    observed:
      display:
        v: A single dose of 3 mg glucagon nasal powder was administered intranasally
  variable definition:
    note:
      text:
        v: All randomized participants who received at least one dose of study drug.
    variable role:
      v: outcome
    observed:
      l: NCT03421379-OtherAdverseEvents
      reference:
        v: #NCT03421379-OtherAdverseEvents
      type:
        v: EvidenceVariable
        l: EvidenceVariable

statistic type:
  text:
    v: Percentage
quantity:
  value:
    v: 0.2113
number affected:
  v: 15
sample size:
  known data count:
    v: 71

Evidence
id:
  v: NCT03421379-AllCauseMortality-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_AllCauseMortality_EG001
title:
  v: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-AllCauseMortality
    reference:
      v: #NCT03421379-AllCauseMortality
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

Evidence
id:
  v: NCT03421379-SeriousAdverseEvents-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_SeriousAdverseEvents_EG001
title:
  v: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-SeriousAdverseEvents
    reference:
      v: #NCT03421379-SeriousAdverseEvents
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

Evidence
id:
  v: NCT03421379-OtherAdverseEvents-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvents_EG001
title:
  v: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvents
    reference:
      v: #NCT03421379-OtherAdverseEvents
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.1857
  number affected:
    v: 13
  sample size:
    known data count:
      v: 70

Evidence
id:
  v: NCT03421379-SeriousAdverseEvent-0-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_SeriousAdverseEvent_0_EG000
title:
  v: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-SeriousAdverseEvent-0
    reference:
      v: #NCT03421379-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-SeriousAdverseEvent-0-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_SeriousAdverseEvent_0_EG001
title:
  v: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-SeriousAdverseEvent-0
    reference:
      v: #NCT03421379-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-SeriousAdverseEvent-0
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Vertigo positional as serious adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Vertigo positional as serious adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Serious Adverse Event
classifier:
  text:
    v: Ear and labyrinth disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-0-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_0_EG000
title:
  v: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-0
    reference:
      v: #NCT03421379-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0282
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-0-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_0_EG001
title:
  v: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-0
    reference:
      v: #NCT03421379-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-0
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Ear pain as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Ear pain as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Ear and labyrinth disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-1-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_1_EG000
title:
  v: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-1
    reference:
      v: #NCT03421379-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0141
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-1-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_1_EG001
title:
  v: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-1
    reference:
      v: #NCT03421379-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-1
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Eye pain as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Eye pain as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Eye disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-2-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_2_EG000
title:
  v: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-2
    reference:
      v: #NCT03421379-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0141
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-2-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_2_EG001
title:
  v: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-2
    reference:
      v: #NCT03421379-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-2
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Eye pruritus as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Eye pruritus as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Eye disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-3-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_3_EG000
title:
  v: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-3
    reference:
      v: #NCT03421379-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0141
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-3-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_3_EG001
title:
  v: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-3
    reference:
      v: #NCT03421379-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-3
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Lacrimation increased as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Lacrimation increased as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Eye disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-4-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_4_EG000
title:
  v: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-4
    reference:
      v: #NCT03421379-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0141
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-4-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_4_EG001
title:
  v: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-4
    reference:
      v: #NCT03421379-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-4
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Diarrhoea as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Diarrhoea as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-5-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_5_EG000
title:
  v: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-5
    reference:
      v: #NCT03421379-OtherAdverseEvent-5
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0704
  number of events:
    v: 5
  number affected:
    v: 5
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-5-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_5_EG001
title:
  v: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-5
    reference:
      v: #NCT03421379-OtherAdverseEvent-5
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.1571
  number of events:
    v: 11
  number affected:
    v: 11
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-5
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Nausea as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Nausea as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-6-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_6_EG000
title:
  v: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-6
    reference:
      v: #NCT03421379-OtherAdverseEvent-6
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0141
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-6-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_6_EG001
title:
  v: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-6
    reference:
      v: #NCT03421379-OtherAdverseEvent-6
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-6
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Toothache as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Toothache as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-7-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_7_EG000
title:
  v: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-7
    reference:
      v: #NCT03421379-OtherAdverseEvent-7
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0282
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-7-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_7_EG001
title:
  v: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-7
    reference:
      v: #NCT03421379-OtherAdverseEvent-7
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0571
  number of events:
    v: 5
  number affected:
    v: 4
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-7
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Vomiting as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Vomiting as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-8-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_8_EG000
title:
  v: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-8
    reference:
      v: #NCT03421379-OtherAdverseEvent-8
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-8-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_8_EG001
title:
  v: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-8
    reference:
      v: #NCT03421379-OtherAdverseEvent-8
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-8
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Feeling abnormal as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Feeling abnormal as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-9-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_9_EG000
title:
  v: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-9
    reference:
      v: #NCT03421379-OtherAdverseEvent-9
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-9-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_9_EG001
title:
  v: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-9
    reference:
      v: #NCT03421379-OtherAdverseEvent-9
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-9
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Cystitis as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Cystitis as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Infections and infestations
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-10-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_10_EG000
title:
  v: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
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variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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variable definition:
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    type:
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EvidenceVariable
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meta:
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title:
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status:
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definition:
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      v: Blood pressure decreased as other adverse event
definition modifier:
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      v: Adverse event assessment type
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    coding:
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      display:
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definition modifier:
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handling:
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classifier:
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classifier:
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    v: Investigations
timing:
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    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
  description:
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  variable role:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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EvidenceVariable
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meta:
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title:
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status:
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definition:
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      v: Blood pressure increased as other adverse event
definition modifier:
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definition modifier:
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handling:
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    v: Other Adverse Event
classifier:
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    v: Investigations
timing:
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    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
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meta:
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name:
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title:
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status:
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variable definition:
  description:
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  variable role:
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  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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    text:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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  variable role:
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variable definition:
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      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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EvidenceVariable
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meta:
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title:
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status:
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definition:
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definition modifier:
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    coding:
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definition modifier:
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    text:
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handling:
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classifier:
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    v: Other Adverse Event
classifier:
  text:
    v: Musculoskeletal and connective tissue disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
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meta:
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name:
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title:
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status:
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variable definition:
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      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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  variable role:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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    text:
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EvidenceVariable
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meta:
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title:
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status:
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definition:
  concept:
    text:
      v: Headache as other adverse event
definition modifier:
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      v: Adverse event assessment type
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    coding:
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      code:
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      display:
        v: Systematic Assessment
definition modifier:
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    text:
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handling:
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classifier:
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    v: Other Adverse Event
classifier:
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    v: Nervous system disorders
timing:
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    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
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meta:
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name:
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title:
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status:
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variable definition:
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    display:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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    text:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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variable definition:
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      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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    text:
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EvidenceVariable
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meta:
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title:
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status:
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definition:
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    text:
      v: Nasal congestion as other adverse event
definition modifier:
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      v: Adverse event assessment type
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    coding:
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definition modifier:
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    text:
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handling:
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classifier:
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    v: Other Adverse Event
classifier:
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    v: Respiratory, thoracic and mediastinal disorders
timing:
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    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
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meta:
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name:
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title:
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status:
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variable definition:
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    display:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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    text:
      v: Percentage
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EvidenceVariable
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meta:
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title:
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status:
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definition:
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    text:
      v: Nasal pruritus as other adverse event
definition modifier:
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      v: Adverse event assessment type
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    coding:
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definition modifier:
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    text:
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handling:
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classifier:
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    v: Other Adverse Event
classifier:
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    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
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meta:
  profile:
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name:
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title:
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status:
  v: active
variable definition:
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    v: Glucagon Nasal Powder
  variable role:
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    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
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    reference:
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    type:
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statistic:
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    text:
      v: Percentage
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Evidence
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meta:
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name:
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title:
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status:
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variable definition:
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  variable role:
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    display:
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variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
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    reference:
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    type:
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statistic:
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    text:
      v: Percentage
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    value:
      v: 0
  number of events:
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  sample size:
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EvidenceVariable
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meta:
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    l: variable-definition
title:
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status:
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definition:
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    text:
      v: Oropharyngeal pain as other adverse event
definition modifier:
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      v: Adverse event assessment type
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definition modifier:
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    text:
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      v: MedDRA 18.1
handling:
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classifier:
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    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
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meta:
  profile:
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name:
  v: NCT03421379_OtherAdverseEvent_17_EG000
title:
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status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
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    l: NCT03421379-OtherAdverseEvent-17
    reference:
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    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0845
  number of events:
    v: 6
  number affected:
    v: 6
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-17-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
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name:
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title:
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status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
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  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
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    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
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    reference:
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    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
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      v: 0
  number of events:
    v: 0
  number affected:
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  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-17
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Rhinalgia as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Rhinalgia as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-18-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_18_EG000
title:
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status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-18
    reference:
      v: #NCT03421379-OtherAdverseEvent-18
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-18-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_18_EG001
title:
  v: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
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    reference:
      v: #NCT03421379-OtherAdverseEvent-18
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-18
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Cold sweat as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Cold sweat as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Skin and subcutaneous tissue disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-19-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_19_EG000
title:
  v: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-19
    reference:
      v: #NCT03421379-OtherAdverseEvent-19
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-19-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_19_EG001
title:
  v: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-19
    reference:
      v: #NCT03421379-OtherAdverseEvent-19
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-19
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Hot flush as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Hot flush as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Vascular disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-20-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_20_EG000
title:
  v: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-20
    reference:
      v: #NCT03421379-OtherAdverseEvent-20
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-20-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
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title:
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status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-20
    reference:
      v: #NCT03421379-OtherAdverseEvent-20
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-20
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Hypertension as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Hypertension as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Vascular disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-21-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_21_EG000
title:
  v: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Nasal Powder
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-21
    reference:
      v: #NCT03421379-OtherAdverseEvent-21
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 71

Evidence
id:
  v: NCT03421379-OtherAdverseEvent-21-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03421379_OtherAdverseEvent_21_EG001
title:
  v: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
status:
  v: active
variable definition:
  description:
    v: Glucagon Hydrochloride Solution
  variable role:
    v: population
  observed:
    display:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM
variable definition:
  note:
    text:
      v: All randomized participants who received at least one dose of study drug.
  variable role:
    v: outcome
  observed:
    l: NCT03421379-OtherAdverseEvent-21
    reference:
      v: #NCT03421379-OtherAdverseEvent-21
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0143
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 70

EvidenceVariable
id:
  v: NCT03421379-OtherAdverseEvent-21
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Peripheral coldness as other adverse event
status:
  v: active
definition:
  concept:
    text:
      v: Peripheral coldness as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 18.1
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Vascular disorders
timing:
  text:
    v: From Baseline to End of Follow-up (Up to 2 Months)

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0203
      l: v2-0203
    code:
      v: ACSN
    display:
      v: Accession ID
  text:
    v: FEvIR Object Identifier
system:
  v: https://fevir.net/FOI
  l: FOI
value:
  v: 399874
assigner:
  display:
    v: Computable Publishing LLC

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03421379-adverse-events-report
assigner:
  display:
    v: Computable Publishing LLC

v: final

coding:
  system:
    v: https://fevir.net/resources/CodeSystem/179423
    l: https://fevir.net/resources/CodeSystem/179423
  code:
    v: OutcomeMeasureReport
  display:
    v: OutcomeMeasureReport
text:
  v: Outcome Measure Report

v: 2025-12-11T20:35:21.032Z

display:
  v: [No author listed.]

v: Adverse Events Report for NCT03421379

l: http://hl7.org/fhir/uv/ebm/Organization/118079
reference:
  v: Organization/118079
type:
  v: Organization
  l: Organization
display:
  v: Computable Publishing LLC

type:
  v: cite-as
target: Markdown
  v: 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.

title:
  v: Events Frequency Threshold
code:
  text:
    v: EventsFrequencyThreshold
text:
  status:
    v: generated
  div:
    v: 0%

title:
  v: Events Time Frame
code:
  text:
    v: EventsTimeFrame
text:
  status:
    v: generated
  div:
    v: From Baseline to End of Follow-up (Up to 2 Months)

title:
  v: Events Description
code:
  text:
    v: EventsDescription
text:
  status:
    v: generated
  div:
    v: All randomized participants who received at least one dose of study drug.

title:
  v: Glucagon Nasal Powder
code:
  text:
    v: EG000 Glucagon Nasal Powder
section:
  title:
    v: Event Group Description
  code:
    text:
      v: EventGroupDescription
  text:
    status:
      v: generated
    div:
      v: A single dose of 3 mg glucagon nasal powder was administered intranasally

title:
  v: Glucagon Hydrochloride Solution
code:
  text:
    v: EG001 Glucagon Hydrochloride Solution
section:
  title:
    v: Event Group Description
  code:
    text:
      v: EventGroupDescription
  text:
    status:
      v: generated
    div:
      v: A single dose of 1 mg glucagon hydrochloride solution was administered IM

title:
  v: Total Mortality
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Mortality
focus:
  l: NCT03421379-AllCauseMortality
  reference:
    v: #NCT03421379-AllCauseMortality
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: All-cause mortality (timeframe for NCT03421379)
entry:
  l: NCT03421379-AllCauseMortality-EG000
  reference:
    v: #NCT03421379-AllCauseMortality-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: All-cause mortality for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-AllCauseMortality-EG001
  reference:
    v: #NCT03421379-AllCauseMortality-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Total Serious Events
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Serious Events
focus:
  l: NCT03421379-SeriousAdverseEvents
  reference:
    v: #NCT03421379-SeriousAdverseEvents
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Serious Adverse Events (timeframe for NCT03421379)
entry:
  l: NCT03421379-SeriousAdverseEvents-EG000
  reference:
    v: #NCT03421379-SeriousAdverseEvents-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-SeriousAdverseEvents-EG001
  reference:
    v: #NCT03421379-SeriousAdverseEvents-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Total Other Events
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Other Events
focus:
  l: NCT03421379-OtherAdverseEvents
  reference:
    v: #NCT03421379-OtherAdverseEvents
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Other Adverse Events (timeframe for NCT03421379)
entry:
  l: NCT03421379-OtherAdverseEvents-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvents-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Other Adverse Events for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvents-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvents-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Serious Event List
code:
  text:
    v: SeriousEventList
section:
  title:
    v: Vertigo positional
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-SeriousAdverseEvent-0
    reference:
      v: #NCT03421379-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Vertigo positional as serious adverse event
  entry:
    l: NCT03421379-SeriousAdverseEvent-0-EG000
    reference:
      v: #NCT03421379-SeriousAdverseEvent-0-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-SeriousAdverseEvent-0-EG001
    reference:
      v: #NCT03421379-SeriousAdverseEvent-0-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Other Event List
code:
  text:
    v: OtherEventList
section:
  title:
    v: Ear pain
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-OtherAdverseEvent-0
    reference:
      v: #NCT03421379-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Ear pain as other adverse event
  entry:
    l: NCT03421379-OtherAdverseEvent-0-EG000
    reference:
      v: #NCT03421379-OtherAdverseEvent-0-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-OtherAdverseEvent-0-EG001
    reference:
      v: #NCT03421379-OtherAdverseEvent-0-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
section:
  title:
    v: Eye pain
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-OtherAdverseEvent-1
    reference:
      v: #NCT03421379-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Eye pain as other adverse event
  entry:
    l: NCT03421379-OtherAdverseEvent-1-EG000
    reference:
      v: #NCT03421379-OtherAdverseEvent-1-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-OtherAdverseEvent-1-EG001
    reference:
      v: #NCT03421379-OtherAdverseEvent-1-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
section:
  title:
    v: Eye pruritus
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-OtherAdverseEvent-2
    reference:
      v: #NCT03421379-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Eye pruritus as other adverse event
  entry:
    l: NCT03421379-OtherAdverseEvent-2-EG000
    reference:
      v: #NCT03421379-OtherAdverseEvent-2-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-OtherAdverseEvent-2-EG001
    reference:
      v: #NCT03421379-OtherAdverseEvent-2-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
section:
  title:
    v: Lacrimation increased
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-OtherAdverseEvent-3
    reference:
      v: #NCT03421379-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Lacrimation increased as other adverse event
  entry:
    l: NCT03421379-OtherAdverseEvent-3-EG000
    reference:
      v: #NCT03421379-OtherAdverseEvent-3-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-OtherAdverseEvent-3-EG001
    reference:
      v: #NCT03421379-OtherAdverseEvent-3-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
section:
  title:
    v: Diarrhoea
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03421379-OtherAdverseEvent-4
    reference:
      v: #NCT03421379-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Diarrhoea as other adverse event
  entry:
    l: NCT03421379-OtherAdverseEvent-4-EG000
    reference:
      v: #NCT03421379-OtherAdverseEvent-4-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379
  entry:
    l: NCT03421379-OtherAdverseEvent-4-EG001
    reference:
      v: #NCT03421379-OtherAdverseEvent-4-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Nausea
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-5
  reference:
    v: #NCT03421379-OtherAdverseEvent-5
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Nausea as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-5-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-5-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-5-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-5-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Toothache
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-6
  reference:
    v: #NCT03421379-OtherAdverseEvent-6
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Toothache as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-6-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-6-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-6-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-6-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Vomiting
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-7
  reference:
    v: #NCT03421379-OtherAdverseEvent-7
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Vomiting as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-7-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-7-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-7-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-7-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Feeling abnormal
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-8
  reference:
    v: #NCT03421379-OtherAdverseEvent-8
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Feeling abnormal as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-8-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-8-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-8-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-8-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Cystitis
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-9
  reference:
    v: #NCT03421379-OtherAdverseEvent-9
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Cystitis as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-9-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-9-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-9-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-9-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Blood pressure decreased
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-10
  reference:
    v: #NCT03421379-OtherAdverseEvent-10
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Blood pressure decreased as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-10-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-10-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-10-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-10-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Blood pressure increased
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-11
  reference:
    v: #NCT03421379-OtherAdverseEvent-11
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Blood pressure increased as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-11-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-11-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-11-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-11-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Back pain
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-12
  reference:
    v: #NCT03421379-OtherAdverseEvent-12
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Back pain as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-12-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-12-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-12-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-12-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Headache
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-13
  reference:
    v: #NCT03421379-OtherAdverseEvent-13
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Headache as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-13-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-13-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Headache as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-13-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-13-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Nasal congestion
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-14
  reference:
    v: #NCT03421379-OtherAdverseEvent-14
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Nasal congestion as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-14-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-14-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-14-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-14-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Nasal pruritus
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-15
  reference:
    v: #NCT03421379-OtherAdverseEvent-15
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Nasal pruritus as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-15-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-15-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-15-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-15-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Oropharyngeal pain
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-16
  reference:
    v: #NCT03421379-OtherAdverseEvent-16
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Oropharyngeal pain as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-16-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-16-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-16-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-16-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Rhinalgia
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-17
  reference:
    v: #NCT03421379-OtherAdverseEvent-17
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Rhinalgia as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-17-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-17-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-17-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-17-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Cold sweat
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-18
  reference:
    v: #NCT03421379-OtherAdverseEvent-18
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Cold sweat as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-18-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-18-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-18-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-18-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Hot flush
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-19
  reference:
    v: #NCT03421379-OtherAdverseEvent-19
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Hot flush as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-19-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-19-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-19-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-19-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Hypertension
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-20
  reference:
    v: #NCT03421379-OtherAdverseEvent-20
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Hypertension as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-20-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-20-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-20-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-20-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379

title:
  v: Peripheral coldness
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03421379-OtherAdverseEvent-21
  reference:
    v: #NCT03421379-OtherAdverseEvent-21
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Peripheral coldness as other adverse event
entry:
  l: NCT03421379-OtherAdverseEvent-21-EG000
  reference:
    v: #NCT03421379-OtherAdverseEvent-21-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379
entry:
  l: NCT03421379-OtherAdverseEvent-21-EG001
  reference:
    v: #NCT03421379-OtherAdverseEvent-21-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379