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 |
|---|---|---|---|---|---|---|---|---|
| Esophageal Deviation | esophageal deviation with IDE device during AF ablation | 0 | None | 2 | 36 | 7 | 36 | View |
| Temperature Monitoring | luminal esophageal standing temperature monitoring alone | 0 | None | 3 | 33 | 4 | 33 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial Flutter | None | Cardiac disorders | None | View |
| Groin Hematoma | None | Renal and urinary disorders | None | View |
| Nausea with abdominal pain | None | Gastrointestinal disorders | None | View |
| Venous Thrombophlebitis | None | Cardiac disorders | None | View |
| Atrial Fibrillation | None | Cardiac disorders | None | View |
| Acute Bronchitis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Urinary Tract Infection | None | Renal and urinary disorders | None | View |