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 |
|---|---|---|---|---|---|---|---|---|
| Engage PA | Engage PA: Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout. | 0 | None | 0 | 19 | 0 | 19 | View |
| Treatment as Usual Plus Fitness Tracker | Treatment as Usual plus (TAU+): The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study. | 0 | None | 0 | 20 | 0 | 20 | View |