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 |
|---|---|---|---|---|---|---|---|---|
| Furosemide + Enhanced Recovery After Surgery (ERAS) | Furosemide 10 mg IV on post-operative day #1 and/or 2, plus ERAS, as described in other arm. | 0 | None | 0 | 62 | 8 | 62 | View |
| Enhanced Recovery After Surgery (ERAS) | ERAS included administration of celecoxib and gabapentin in the pre-operative setting, single-injection intrathecal analgesic administration immediately prior to induction of general anesthesia, post-operative administration of scheduled acetaminophen and nonsteroidal anti-inflammatory drug (NSAID) or tramadol, and discontinuation of IV fluids by 0800 on postoperative day (POD) 1. Intraoperative fluid administration was dependent on the individual anesthesia provider with no unified commitment to either zero balance or goal-directed fluid therapy. Fluid status was determined based on patient weight. Patients were weighed preoperatively and daily post-operatively using either a bed scale or a unit-based scale. | 0 | None | 0 | 61 | 3 | 61 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urine leak | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Increased heart rate | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Increased temperature | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematoma/Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Decreased Potassium | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Increased Serum Creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Decreased blood pressure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |