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 |
|---|---|---|---|---|---|---|---|---|
| Supervised (SUP-PA) | Weight loss intervention that focuses on supervised physical activity and involves an energy restricted diet. Physical activity will be supervised by trained staff. Supervised (SUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity. | 0 | None | 0 | 17 | 0 | 17 | View |
| Step-based (STEP) | Weight loss intervention that focuses on unsupervised physical activity prescribed as steps/day and involves an energy restricted diet (identical diet to SUP-PA and UNSUP-PA). Physical activity will be self-monitored and a pedometer will be used to track steps/day. Step-based (STEP): Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 "brisk" steps/day. | 0 | None | 0 | 18 | 0 | 18 | View |
| Unsupervised (UNSUP-PA) | Weight loss intervention that focuses on unsupervised physical activity (identical dose to SUP-PA) and involves an energy restricted diet (identical diet to SUP-PA). Physical activity will be self-monitored but no activity tracker will be used as an intervention tool. Unsupervised (UNSUP-PA): Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity. | 0 | None | 0 | 17 | 0 | 17 | View |