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 |
|---|---|---|---|---|---|---|---|---|
| Convective Pre-warming | Undergo convective warming during the preoperative preparations, completed for a minimum of 60 minutes prior to entering the operating room Bair Hugger™ Temperature Management Unit Model 750: Forced-air temperature management unit used for preoperative and intraoperative participant warming 3M™ Bair Paws™ Flex Gown: Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming | 0 | None | 0 | 6 | 0 | 6 | View |
| Standard of Care | Undergo standard of care, which includes providing each patient with blankets and sheets, as well as more blankets on patient request. | 0 | None | 0 | 4 | 0 | 4 | View |