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 |
|---|---|---|---|---|---|---|---|---|
| Simvastatin | Participants were randomized into the Simvastatin arm of this trial. | None | None | 11 | 20 | 0 | 20 | View |
| Placebo | Participants were randomized into the placebo arm of this trial. | None | None | 3 | 16 | 0 | 16 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| UTI | None | Renal and urinary disorders | None | View |
| Hypotension | None | Cardiac disorders | None | View |
| Penile pain | None | Reproductive system and breast disorders | None | View |
| Wound infection | None | Infections and infestations | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Catheter discomfort | None | Renal and urinary disorders | None | View |
| Bloody drainage from wound | None | Infections and infestations | None | View |