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 |
|---|---|---|---|---|---|---|---|---|
| Control Group | Continued with usual activity and care, no intervention | None | None | 0 | 79 | 0 | 79 | View |
| Aquatic Exercise | Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility | None | None | 0 | 79 | 0 | 79 | View |
| Aquatic Exercise Plus Education | Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls. | None | None | 0 | 79 | 0 | 79 | View |