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: 2025-12-24 @ 11:04 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT02656069
Description: None
Frequency Threshold: 2
Time Frame: For the first intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the first intervention and prior to receipt of the second intervention, 7-28 days later. For the second intervention, treatment emergent adverse events were defined as adverse events occurring at any time after receipt of the second intervention and prior to completion of the follow-up evaluation visit occurring 3-14 days later.
Study: NCT02656069
Study Brief: Safety and Efficacy of G-Pen Compared to Lilly Glucagon for Hypoglycemia Rescue in Adult Type 1 Diabetics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lilly Glucagon A single 1 mg subcutaneous (SC) injection of Lilly Glucagon 0 None 1 79 16 79 View
G-Pen A single 1 mg subcutaneous (SC) injection of G-Pen™ (glucagon injection) 0 None 0 78 24 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hyperinsulinemic hypoglycemia NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (20.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.0) View