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 |
|---|---|---|---|---|---|---|---|---|
| Group A (High Platelet Reactivity - Tirofiban) | Patients with high platelet reactivity unit (230 or higher) Tirofiban administered dose: 0.4 μg/kg/min continuous infusion for 30 min and then 0.10 μg/kg/min continuous infusion for 12 h Tirofiban | 2 | None | 0 | 30 | 4 | 30 | View |
| Control C1 (High Platelet Reactivity - no Tirofiban) | Patients with high platelet reactivity unit (230 or higher) Tirofiban was not administered | 0 | None | 0 | 30 | 1 | 30 | View |
| Control C2 (Low Platelet Reactivity - no Tirofiban) | Patients with low platelet reactivity unit (less than 230) Tirofiban was not administered | 0 | None | 0 | 78 | 8 | 78 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Minor bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |