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 Intensity of Anticoagulation | After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5). Warfarin | 12 | None | 24 | 245 | 0 | 245 | View |
| D-dimer-guided Adjustmentd of Anticoagutlation Intensity | The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level. Warfarin | 4 | None | 9 | 245 | 0 | 245 | View |
| Low Intensity Without Adjustment | The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Warfarin | 5 | None | 20 | 242 | 0 | 242 | View |