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 |
|---|---|---|---|---|---|---|---|---|
| Standard of Care | Managed by primary care physicians with recommendation to follow the guidelines for standard appropriate diabetes care. | 19 | None | 28 | 447 | 0 | 447 | View |
| Coronary Computed Tomographic Angiography | Received medical management recommendations based on the results of their CT scans. | 16 | None | 29 | 452 | 0 | 452 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-Fatal MI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization for Unstable Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization for Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Stroke or Carotid Revascularization Procedure | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Limb Amputation or Peripheral Vascular Revascularization Procedure | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |