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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT00063635
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00063635
Study Brief: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin Metformin, 500 mg, twice daily None None 7 57 17 57 View
Vitamin E Vitamin E, 400 IU, twice daily None None 6 58 17 58 View
Placebo Matching placebo None None 14 58 18 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetes None Endocrine disorders None View
Elevated serum glucose None Endocrine disorders None View
Hepatobiliary/pancreas None Hepatobiliary disorders None View
Hepatotoxicity None Hepatobiliary disorders None View
Pain None General disorders None View
Syncope None Cardiac disorders None View
None None General disorders None View
Depression None General disorders None View
Suicide None General disorders None View
Airway constriction/bronchospasm None Respiratory, thoracic and mediastinal disorders None View
Appendicitis None Gastrointestinal disorders None View
Cholecystitis None Gastrointestinal disorders None View
Constipation None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Unspecified- Mild None General disorders None View
Unspecified- Moderate None General disorders None View