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 |
|---|---|---|---|---|---|---|---|---|
| Duck Duck Punch | Subjects in this arm will engage in Duck Duck Punch Play, a custom designed computer game developed for stroke rehabilitation for 6 weeks. Duck Duck Punch Play: The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors. | 0 | None | 0 | 33 | 1 | 33 | View |
| Commercially Available Game | Subjects in this arm will engage in a Commercially Available Game Play off-the-shelf computer game for 6 weeks. Commercially Available Game Play: The behavioral intervention will include playing a hands-free video game available off-the-shelf. | 0 | None | 0 | 33 | 1 | 33 | View |