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 |
|---|---|---|---|---|---|---|---|---|
| Ascorbic Acid | Ascorbi acid 500 mg \[per day | 1 | None | 6 | 44 | 0 | 44 | View |
| Placebo | Placebo for atorvastatin and ascorbic acid | 1 | None | 7 | 42 | 0 | 42 | View |
| Atorvastatin | Atorvastatin 40 or 80 mg | 0 | None | 3 | 22 | 0 | 22 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial infaction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Unstable angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| CVA/TIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Venticular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Other CVD event | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |