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 |
|---|---|---|---|---|---|---|---|---|
| 1 Computer-based Program | Use of Computer-based Program for 12 weeks Computer-based Program: The intervention group will receive an initial training session which will include a demonstration of the layout and main features of the computer-based program and some instructions on how to navigate around the different sections of the program. As a minimum level of use, participants will be asked to use the self-monitoring and goal setting aspects of the computer-based program on at least a weekly basis. | None | None | 0 | 41 | 0 | 41 | View |
| 2 Control | Usual care and list of useful websites | None | None | 0 | 43 | 0 | 43 | View |