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 |
|---|---|---|---|---|---|---|---|---|
| CAM Walker Boot for >2 Weeks | All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study. | 0 | None | 0 | 46 | 0 | 46 | View |