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 |
|---|---|---|---|---|---|---|---|---|
| Heat Therapy Group | Group will undergo 30 sessions of heat therapy over approximately 10 weeks. Sessions will require subjects to be immersed in hot water for up to 45 minutes per session. Heat Therapy Group: 30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session | 0 | None | 0 | 21 | 0 | 21 | View |
| Aerobic Exercise Group | Group will undergo 30 sessions of aerobic exercise training over approximately 10 weeks. Sessions will require subjects to exercise on a cycle ergometer for up to 45 minutes per session. Aerobic Exercise Group: 30 sessions of aerobic exercise training consisting of a 5-minute warm-up of seated upright cycling at 30% VO2 peak, followed by 40 minutes of cycling at 60% VO2 peak, then a 5-minute cool down at 30% VO2 peak. | 0 | None | 0 | 20 | 0 | 20 | View |