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 |
|---|---|---|---|---|---|---|---|---|
| E-Motivate Group | Participants completed a 20-minute tablet app, called e-Motivate and received usual care. In particular, participants in the e-motivate group completed a 20-minute, motivational interviewing informed tablet app in the clinic after they received a physician referral for a screening colonoscopy. The tablet app consisted of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary). | 0 | None | 0 | 29 | 0 | 29 | View |
| Usual Care Group | Participants in the usual care group received standard clinical care for patients referred for a screening colonoscopy. In particular, they received patient navigation (e.g., assistance scheduling the screening colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions). | 0 | None | 0 | 34 | 0 | 34 | View |