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 |
|---|---|---|---|---|---|---|---|---|
| Phase I (Standard Follow up, Physical Activity Measurement) | Patients undergo standard face-to-face follow up visits at 2, 6, 12, and 24 weeks after surgery. Patients also undergo a physical activity assessment over 15 minutes. Physical Activity Measurement: Undergo physical activity measurement Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Standard Follow-Up Care: Undergo standard follow-up care Survey Administration: Ancillary studies | 6 | None | 0 | 18 | 0 | 18 | View |
| Phase II (Mobile Surveillance) | Patients undergo standard face-to-face follow up visits as in Group I. Patients also undergo mobile surveillance comprising use of a mobile device application to send photos and videos to study staff and engage in video conferences at 3, 7, 13, and 25 weeks after surgery. Monitoring Device: Undergo surgical wound and physical activity monitoring Physical Activity Measurement: Undergo physical activity measurement Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Standard Follow-Up Care: Undergo standard follow-up care Survey Administration: Ancillary studies | 5 | None | 0 | 52 | 0 | 52 | View |