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 |
|---|---|---|---|---|---|---|---|---|
| PlayTest! Game | Participants who were randomized to the intervention arm of the project, played the PlayTest! game on their assigned iPad, once per week for an hour, over the course of 4-5 weeks. | 0 | None | 0 | 145 | 0 | 145 | View |
| Control Games | Participants who were randomized to the control arm were provided a menu of attention control games to choose from on their iPads that had no content related to HTC or HIV. Some examples of control games that participants could play are: The Sims, Harry Potter, Subway Surfer, Tetris. Participants played the choice of control games on their assigned iPad, once per week for and hour, over the course of 4-5 weeks. | 0 | None | 0 | 142 | 0 | 142 | View |