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 | This group receives no kind of feedback during the intervention period | None | None | 0 | 0 | 0 | 56 | View |
| Display Group | Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display | None | None | 0 | 3 | 0 | 57 | View |
| Coaching Group | Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress | None | None | 0 | 5 | 0 | 57 | View |
| Step Group | This group receives feedback about the daily amount of steps by means of a pedometer. | None | None | 0 | 0 | 0 | 57 | View |