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 |
|---|---|---|---|---|---|---|---|---|
| ACEI Omission | Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose. ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur. | 0 | None | 4 | 137 | 0 | 137 | View |
| ACEI Continuation | Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose. ACEI continuation: These chronic medications will be given without interruption preoperatively. | 0 | None | 1 | 138 | 0 | 138 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| MACE | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |