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 |
|---|---|---|---|---|---|---|---|---|
| Experimental Condition | Participants in this condition viewed a movie without guns. The movie (National Treasure or The Rocketeer) was edited to remove guns from scenes. Movies without Guns: Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes | None | None | 0 | 54 | 0 | 54 | View |
| Control Condition | Participants in this condition viewed a movie with guns, as it was filmed and distributed. The actual scenes in the movie (National Treasure or The Rocketeer) was not edited, but the same scenes were used as the Experimental Condition | None | None | 0 | 50 | 0 | 50 | View |