Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:24 AM
NCT ID: NCT01556594
Description: All enrolled participants who received at least one dose of glucagon (SC Glucagon or NG).
Frequency Threshold: 0
Time Frame: First dose of study drug (Day 1) until post-study completion (Day 38)
Study: NCT01556594
Study Brief: Safety and Efficacy of a Novel Glucagon Formulation in Type 1 Diabetic Patients Following Insulin-induced Hypoglycemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NG 2 mg NG dose of 2 mg None None 0 18 15 18 View
NG 3 mg NG dose of 3 mg None None 0 8 8 8 View
NG 1 mg NG dose of 1 mg None None 0 12 9 12 View
SC Glucagon SC glucagon injection 1 mg None None 0 18 16 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Lacrimation Increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Ear pruritus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Catheter Site Bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Catheter Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hunger SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vessel Puncture Site Bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain in Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal Dryness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal Pruritus SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cold Sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View