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 |
|---|---|---|---|---|---|---|---|---|
| AngioJet Ultra PE Thrombectomy System | Patients are treated with the AngioJet Ultra PE Thrombectomy System AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System | None | None | 4 | 7 | 1 | 7 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary Embolism, Re-occurring | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Bowel Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Macrohematuria (presence of blood cells in urine) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |