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 @ 5:17 PM
Ignite Modification Date: 2025-12-25 @ 2:54 PM
NCT ID: NCT02516150
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected by subject report throughout the duration of each clamp visit, which was up to 12 hours long.
Study: NCT02516150
Study Brief: Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Glucagon Without Ethanol Volunteers will not receive an infusion of IV ethanol at this visit. 50 micrograms of glucagon will be administered via subcutaneous injection. Glucagon: injection of 50 micrograms of glucagon 0 None 0 15 0 15 View
Glucagon With Ethanol Volunteers will receive an infusion of IV ethanol that will increase their BAC (blood alcohol content) to 0.1. Once their BAC has stabilized at 0.1%, 50 micrograms of glucagon will be administered via subcutaneous injection. Ethanol: IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1% Glucagon: injection of 50 micrograms of glucagon 0 None 0 15 3 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest tightness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurred vision/dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View