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 |
|---|---|---|---|---|---|---|---|---|
| Cell Saver | Standard method of returning the residual pump volume to the patient as washed, centrifuged cells (control group) | 1 | None | 2 | 50 | 14 | 50 | View |
| Hemobag® | Hemobag® method of returning residual CPB blood (study group) method of returning residual CPB blood ( Hemobag®): The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB). | 2 | None | 0 | 50 | 12 | 50 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Low output failure | None | Cardiac disorders | None | View |