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 |
|---|---|---|---|---|---|---|---|---|
| Frequent User Arm | Park users will be able to earn rewards or prizes by coming more frequently to the park Frequent User: Participants can become eligible for prizes by visiting the park more frequently | None | None | 0 | 12 | 0 | 12 | View |
| Free Physical Activity Classes/Programs | We will offer at least 100 free physical activity classes at the park Free physical activity classes: 100 hours of free activity classes will be provided | None | None | 0 | 12 | 0 | 12 | View |
| Combined Arm | We will offer free classes and the frequent user program at the park Free physical activity classes: 100 hours of free activity classes will be provided Frequent User: Participants can become eligible for prizes by visiting the park more frequently | None | None | 0 | 12 | 0 | 12 | View |
| Control | Business as usual, no special physical activity programs offered | None | None | 0 | 12 | 0 | 12 | View |