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 |
|---|---|---|---|---|---|---|---|---|
| Study Group | treatment of DVT with anticoagulation (rivaroxaban), elastic compression stockings and additional prescription of diosmin Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month Diosmin: 600 mg q.d. for 12 month compression stockings: above knee stocking for 12 month | 0 | None | 0 | 45 | 5 | 45 | View |
| Control Group | standard treatment of DVT with anticoagulation (rivaroxaban) and elastic compression stockings Rivaroxaban: 15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month compression stockings: above knee stocking for 12 month | 0 | None | 0 | 45 | 4 | 45 | View |