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 Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG000 Profile: NonComparativeEvidence name: NCT03421379_SeriousAdverseEvents_EG000 title: Serious Adverse Events for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvents_EG000 title: Other Adverse Events for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0.2113 numberAffected: 15 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-AllCauseMortality-EG001 Profile: NonComparativeEvidence name: NCT03421379_AllCauseMortality_EG001 title: All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable All-cause mortality (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvents-EG001 Profile: NonComparativeEvidence name: NCT03421379_SeriousAdverseEvents_EG001 title: Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0.0143 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvents-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvents_EG001 title: Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Other Adverse Events (timeframe for NCT03421379) statistic statisticType: Percentage quantity: 0.1857 numberAffected: 13 SampleSizes - KnownDataCount * 70 Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG000 Profile: NonComparativeEvidence name: NCT03421379_SeriousAdverseEvent_0_EG000 title: Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Vertigo positional as serious adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-SeriousAdverseEvent-0-EG001 Profile: NonComparativeEvidence name: NCT03421379_SeriousAdverseEvent_0_EG001 title: Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Vertigo positional as serious adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-SeriousAdverseEvent-0 Profile: VariableDefinition title: Vertigo positional as serious adverse event status: Active Definitions - Concept * Vertigo positional as serious adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Serious Adverse Event, Ear and labyrinth disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_0_EG000 title: Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Ear pain as other adverse event statistic statisticType: Percentage quantity: 0.0282 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-0-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_0_EG001 title: Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Ear pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-0 Profile: VariableDefinition title: Ear pain as other adverse event status: Active Definitions - Concept * Ear pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Ear and labyrinth disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_1_EG000 title: Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Eye pain as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-1-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_1_EG001 title: Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Eye pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-1 Profile: VariableDefinition title: Eye pain as other adverse event status: Active Definitions - Concept * Eye pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Eye disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_2_EG000 title: Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Eye pruritus as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-2-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_2_EG001 title: Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Eye pruritus as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-2 Profile: VariableDefinition title: Eye pruritus as other adverse event status: Active Definitions - Concept * Eye pruritus as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Eye disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_3_EG000 title: Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Lacrimation increased as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-3-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_3_EG001 title: Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Lacrimation increased as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-3 Profile: VariableDefinition title: Lacrimation increased as other adverse event status: Active Definitions - Concept * Lacrimation increased as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Eye disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_4_EG000 title: Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Diarrhoea as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-4-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_4_EG001 title: Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Diarrhoea as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-4 Profile: VariableDefinition title: Diarrhoea as other adverse event status: Active Definitions - Concept * Diarrhoea as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_5_EG000 title: Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nausea as other adverse event statistic statisticType: Percentage quantity: 0.0704 numberOfEvents: 5 numberAffected: 5 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-5-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_5_EG001 title: Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nausea as other adverse event statistic statisticType: Percentage quantity: 0.1571 numberOfEvents: 11 numberAffected: 11 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-5 Profile: VariableDefinition title: Nausea as other adverse event status: Active Definitions - Concept * Nausea as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_6_EG000 title: Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Toothache as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-6-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_6_EG001 title: Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Toothache as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-6 Profile: VariableDefinition title: Toothache as other adverse event status: Active Definitions - Concept * Toothache as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_7_EG000 title: Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Vomiting as other adverse event statistic statisticType: Percentage quantity: 0.0282 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-7-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_7_EG001 title: Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Vomiting as other adverse event statistic statisticType: Percentage quantity: 0.0571 numberOfEvents: 5 numberAffected: 4 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-7 Profile: VariableDefinition title: Vomiting as other adverse event status: Active Definitions - Concept * Vomiting as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_8_EG000 title: Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Feeling abnormal as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-8-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_8_EG001 title: Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Feeling abnormal as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-8 Profile: VariableDefinition title: Feeling abnormal as other adverse event status: Active Definitions - Concept * Feeling abnormal as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_9_EG000 title: Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Cystitis as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-9-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_9_EG001 title: Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Cystitis as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-9 Profile: VariableDefinition title: Cystitis as other adverse event status: Active Definitions - Concept * Cystitis as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Infections and infestations Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_10_EG000 title: Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Blood pressure decreased as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-10-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_10_EG001 title: Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Blood pressure decreased as other adverse event statistic statisticType: Percentage quantity: 0.0286 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-10 Profile: VariableDefinition title: Blood pressure decreased as other adverse event status: Active Definitions - Concept * Blood pressure decreased as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Investigations Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_11_EG000 title: Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Blood pressure increased as other adverse event statistic statisticType: Percentage quantity: 0.0563 numberOfEvents: 4 numberAffected: 4 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-11-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_11_EG001 title: Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Blood pressure increased as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-11 Profile: VariableDefinition title: Blood pressure increased as other adverse event status: Active Definitions - Concept * Blood pressure increased as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Investigations Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_12_EG000 title: Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Back pain as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-12-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_12_EG001 title: Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Back pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-12 Profile: VariableDefinition title: Back pain as other adverse event status: Active Definitions - Concept * Back pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_13_EG000 title: Headache as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Headache as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-13-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_13_EG001 title: Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Headache as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-13 Profile: VariableDefinition title: Headache as other adverse event status: Active Definitions - Concept * Headache as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Nervous system disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_14_EG000 title: Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nasal congestion as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-14-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_14_EG001 title: Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nasal congestion as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-14 Profile: VariableDefinition title: Nasal congestion as other adverse event status: Active Definitions - Concept * Nasal congestion as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_15_EG000 title: Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nasal pruritus as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-15-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_15_EG001 title: Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Nasal pruritus as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-15 Profile: VariableDefinition title: Nasal pruritus as other adverse event status: Active Definitions - Concept * Nasal pruritus as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_16_EG000 title: Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Oropharyngeal pain as other adverse event statistic statisticType: Percentage quantity: 0.0141 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-16-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_16_EG001 title: Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Oropharyngeal pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-16 Profile: VariableDefinition title: Oropharyngeal pain as other adverse event status: Active Definitions - Concept * Oropharyngeal pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_17_EG000 title: Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Rhinalgia as other adverse event statistic statisticType: Percentage quantity: 0.0845 numberOfEvents: 6 numberAffected: 6 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-17-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_17_EG001 title: Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Rhinalgia as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-17 Profile: VariableDefinition title: Rhinalgia as other adverse event status: Active Definitions - Concept * Rhinalgia as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_18_EG000 title: Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Cold sweat as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-18-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_18_EG001 title: Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Cold sweat as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-18 Profile: VariableDefinition title: Cold sweat as other adverse event status: Active Definitions - Concept * Cold sweat as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Skin and subcutaneous tissue disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_19_EG000 title: Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Hot flush as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-19-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_19_EG001 title: Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Hot flush as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-19 Profile: VariableDefinition title: Hot flush as other adverse event status: Active Definitions - Concept * Hot flush as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Vascular disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_20_EG000 title: Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Hypertension as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-20-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_20_EG001 title: Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Hypertension as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-20 Profile: VariableDefinition title: Hypertension as other adverse event status: Active Definitions - Concept * Hypertension as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Vascular disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months) Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG000 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_21_EG000 title: Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379 status: Active variableDefinition description: Glucagon Nasal Powder variableRole: Population observed: A single dose of 3 mg glucagon nasal powder was administered intranasally variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Peripheral coldness as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 71 Generated Narrative: Evidence #NCT03421379-OtherAdverseEvent-21-EG001 Profile: NonComparativeEvidence name: NCT03421379_OtherAdverseEvent_21_EG001 title: Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379 status: Active variableDefinition description: Glucagon Hydrochloride Solution variableRole: Population observed: A single dose of 1 mg glucagon hydrochloride solution was administered IM variableDefinition note: All randomized participants who received at least one dose of study drug. variableRole: Outcome observed: EvidenceVariable Peripheral coldness as other adverse event statistic statisticType: Percentage quantity: 0.0143 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 70 Generated Narrative: EvidenceVariable #NCT03421379-OtherAdverseEvent-21 Profile: VariableDefinition title: Peripheral coldness as other adverse event status: Active Definitions - Concept * Peripheral coldness as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 18.1 handling: boolean variable classifier: Other Adverse Event, Vascular disorders Timings - Text * From Baseline to End of Follow-up (Up to 2 Months)
All-cause mortality (timeframe for NCT03421379)
From Baseline to End of Follow-up (Up to 2 Months)
Serious Adverse Events (timeframe for NCT03421379)
Other Adverse Events (timeframe for NCT03421379)
All-cause mortality for Glucagon Nasal Powder in NCT03421379
A single dose of 3 mg glucagon nasal powder was administered intranasally
All randomized participants who received at least one dose of study drug.
Serious Adverse Events for Glucagon Nasal Powder in NCT03421379
Other Adverse Events for Glucagon Nasal Powder in NCT03421379
All-cause mortality for Glucagon Hydrochloride Solution in NCT03421379
A single dose of 1 mg glucagon hydrochloride solution was administered IM
Serious Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
Other Adverse Events for Glucagon Hydrochloride Solution in NCT03421379
Vertigo positional as serious adverse event for Glucagon Nasal Powder in NCT03421379
Vertigo positional as serious adverse event for Glucagon Hydrochloride Solution in NCT03421379
Vertigo positional as serious adverse event
Source Vocabulary for Adverse Event Definition
Ear pain as other adverse event for Glucagon Nasal Powder in NCT03421379
Ear pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Eye pain as other adverse event for Glucagon Nasal Powder in NCT03421379
Eye pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Eye pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
Eye pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Lacrimation increased as other adverse event for Glucagon Nasal Powder in NCT03421379
Lacrimation increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Lacrimation increased as other adverse event
Diarrhoea as other adverse event for Glucagon Nasal Powder in NCT03421379
Diarrhoea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Nausea as other adverse event for Glucagon Nasal Powder in NCT03421379
Nausea as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Toothache as other adverse event for Glucagon Nasal Powder in NCT03421379
Toothache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Vomiting as other adverse event for Glucagon Nasal Powder in NCT03421379
Vomiting as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Feeling abnormal as other adverse event for Glucagon Nasal Powder in NCT03421379
Feeling abnormal as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Cystitis as other adverse event for Glucagon Nasal Powder in NCT03421379
Cystitis as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Blood pressure decreased as other adverse event for Glucagon Nasal Powder in NCT03421379
Blood pressure decreased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Blood pressure decreased as other adverse event
Blood pressure increased as other adverse event for Glucagon Nasal Powder in NCT03421379
Blood pressure increased as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Blood pressure increased as other adverse event
Back pain as other adverse event for Glucagon Nasal Powder in NCT03421379
Back pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Musculoskeletal and connective tissue disorders
Headache as other adverse event for Glucagon Nasal Powder in NCT03421379
Headache as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Nasal congestion as other adverse event for Glucagon Nasal Powder in NCT03421379
Nasal congestion as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Respiratory, thoracic and mediastinal disorders
Nasal pruritus as other adverse event for Glucagon Nasal Powder in NCT03421379
Nasal pruritus as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Oropharyngeal pain as other adverse event for Glucagon Nasal Powder in NCT03421379
Oropharyngeal pain as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Oropharyngeal pain as other adverse event
Rhinalgia as other adverse event for Glucagon Nasal Powder in NCT03421379
Rhinalgia as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Cold sweat as other adverse event for Glucagon Nasal Powder in NCT03421379
Cold sweat as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Hot flush as other adverse event for Glucagon Nasal Powder in NCT03421379
Hot flush as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Hypertension as other adverse event for Glucagon Nasal Powder in NCT03421379
Hypertension as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Peripheral coldness as other adverse event for Glucagon Nasal Powder in NCT03421379
Peripheral coldness as other adverse event for Glucagon Hydrochloride Solution in NCT03421379
Peripheral coldness as other adverse event
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.