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 |
|---|---|---|---|---|---|---|---|---|
| Post-Enrollment Through Baseline Measures, Pre-use | all participants prior to use of either device (active or sham) | 0 | None | 0 | 99 | 3 | 99 | View |
| Active | All participants while using active device | 0 | None | 0 | 86 | 19 | 86 | View |
| Active-Washout Period | All participants in the washout period after active device | 0 | None | 0 | 80 | 9 | 80 | View |
| Sham-Washout Period | ll participants in the washout period following sham device | 0 | None | 0 | 82 | 12 | 82 | View |
| Post-Study Monitoring (PSM) | all participants in post-study monitoring | 0 | None | 0 | 76 | 1 | 76 | View |
| Sham | All participants while on sham device | 0 | None | 0 | 89 | 16 | 89 | View |