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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT01483651
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT01483651
Study Brief: Physiologic Response to Glucagon at Varying Insulin Levels
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Insulin Infusion Regular insulin infused at lowest level with glucagon administration. None None 0 10 7 10 View
Medium Insulin Infusion Regular insulin infused at medium level with glucagon administration. None None 0 9 8 9 View
High Insulin Infusion regular insulin infused at highest level with glucagon administration. None None 0 10 5 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
excessive thirst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
extravasation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dermititis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
ketosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View