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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 1 | Motivational enhancement therapy Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH. | None | None | 7 | 70 | 0 | 70 | View |
| Arm 2 | health education intervention Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training. | None | None | 14 | 69 | 0 | 69 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Liver failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Alcohol intoxication | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| myocardial infarction | None | Cardiac disorders | None | View |
| GI distress | None | Hepatobiliary disorders | None | View |
| fracture | None | Musculoskeletal and connective tissue disorders | None | View |
| chest pain | None | Cardiac disorders | None | View |
| psychiatric symptoms | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |