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 |
|---|---|---|---|---|---|---|---|---|
| Mobile App Attention Control | All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness. Mobile app attention control: The control app provides ecological momentary assessment and psychoeducation about illness. | 0 | None | 9 | 23 | 0 | 23 | View |
| Mobile After-Care Support (MACS) App | All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention. Mobile After-Care Support (MACS) app: The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning. | 0 | None | 11 | 19 | 0 | 19 | View |