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 |
|---|---|---|---|---|---|---|---|---|
| Concurrent Exercise Group, CE | Participants conduct 5-min warm up, 12-min aerobic exercise, 13-min resistance exercise, and 5-min cool down. concurrent exercise: Participants conduct warm up for 5-min, aerobic exercise for 12-min, resistance exercise for 13-min, and 5-min cool down. | 0 | None | 0 | 26 | 0 | 26 | View |
| Aerobic Exercise Group, AE | Participants conduct 5-min warm up, 25-min aerobic exercise, and 5-min cool down. aerobic exercise: Participants conduct warm up for 5-min, resistance training for 25-min, and 5-min cool down. | 0 | None | 0 | 26 | 0 | 26 | View |
| Reading Control Group, RC | Participants conduct reading for 35 minutes. | 0 | None | 0 | 26 | 0 | 26 | View |