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 |
|---|---|---|---|---|---|---|---|---|
| Interactive Voice Recognition (IVR) | usual care plus automated phone calls | 146 | None | 21 | 7247 | 0 | 7247 | View |
| Enhanced IVR (IVR+) | usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence | 140 | None | 22 | 7250 | 0 | 7250 | View |
| Usual Care (UC) | usual medical care | 141 | None | 25 | 7255 | 0 | 7255 | View |