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 |
|---|---|---|---|---|---|---|---|---|
| Unfractionated Heparin Group | Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion | 2 | None | 7 | 14 | 0 | 14 | View |
| Bivalirudin Group | Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion | 3 | None | 7 | 16 | 0 | 16 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Major bleeding event | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |