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 |
|---|---|---|---|---|---|---|---|---|
| Pilot Study: Violent Shooter | 20 participants assigned to play a violent shooter game | 0 | None | 0 | 20 | 0 | 20 | View |
| Pilot Study: Non-violent Shooter | 20 participants assigned to play a non-violent shooter game | 0 | None | 0 | 20 | 0 | 20 | View |
| Study Proper: Violent Shooter | 113 participants assigned to play a violent shooter game | 0 | None | 0 | 113 | 0 | 113 | View |
| Study Proper: Non-violent Shooter | 115 participants assigned to play a non-violent shooter game | 0 | None | 0 | 115 | 0 | 115 | View |
| Study Proper: Non-violent Game | 59 participants assigned to play a non-violent game | 0 | None | 0 | 59 | 0 | 59 | View |