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 |
|---|---|---|---|---|---|---|---|---|
| Ezetimibe/Simvastatin | Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks | None | None | 2 | 321 | 0 | 321 | View |
| Doubling Statin Dose | simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. | None | None | 1 | 162 | 0 | 162 | View |
| Rosuvastatin | Rosuvastatin 10 mg tablets, taken once daily for six weeks. | None | None | 2 | 323 | 0 | 323 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Arterial thrombosis limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |