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 |
|---|---|---|---|---|---|---|---|---|
| Tai Chi Exercise | Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor. | 0 | None | 0 | 16 | 0 | 16 | View |
| Balance Recovery Training | Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks. | 0 | None | 0 | 19 | 0 | 19 | View |