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 |
|---|---|---|---|---|---|---|---|---|
| Pre-FE | Outcome assessed pre-forced exercise. All participants completed a forced exercise (FE) and voluntary exercise (VE) session on a stationary bike. The order of the exercise sessions was randomized for each participant. Outcome measures were assessed Pre- and Post-Exercise. Exercise sessions and outcome measures were performed OFF PD medication. | 0 | None | 0 | 15 | 0 | 15 | View |
| Post-FE | Outcome assessed post-forced exercise. All participants completed a forced exercise (FE) and voluntary exercise (VE) session on a stationary bike. The order of the exercise sessions was randomized for each participant. Outcome measures were assessed Pre- and Post-Exercise. Exercise sessions and outcome measures were performed OFF PD medication. | 0 | None | 0 | 15 | 0 | 15 | View |
| Pre-VE | Outcome assessed pre-voluntary exercise. All participants completed a forced exercise (FE) and voluntary exercise (VE) session on a stationary bike. The order of the exercise sessions was randomized for each participant. Outcome measures were assessed Pre- and Post-Exercise. Exercise sessions and outcome measures were performed OFF PD medication. | 0 | None | 0 | 15 | 0 | 15 | View |
| Post-VE | Outcome assessed post-voluntary exercise. All participants completed a forced exercise (FE) and voluntary exercise (VE) session on a stationary bike. The order of the exercise sessions was randomized for each participant. Outcome measures were assessed Pre- and Post-Exercise. Exercise sessions and outcome measures were performed OFF PD medication. | 0 | None | 0 | 15 | 0 | 15 | View |