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 |
|---|---|---|---|---|---|---|---|---|
| Clinicians (B3 Buddy) | Clinicians receive a short instructional session, secure the urinary drainage bag to the patient using the B3 Buddy device. Clinicians also assist patient with walking and then remove the device and return urinary drainage bag to the standard position on study. Assistance: Assist patient with walking approximately 90 feet Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Secure the urinary drainage bag to the patient using the B3 Buddy device Questionnaire Administration: Ancillary studies Remove: Remove the device and return urinary drainage bag to the standard position | 0 | None | 0 | 20 | 0 | 20 | View |
| Patients (B3 Buddy) | Patients receive a short instructional session, wear the B3 Buddy device to secure urinary drainage bag and walk approximately 90 feet before urinary drainage bag is returned to the standard position on study. Educational Intervention: Receive a short instructional session Medical Device Usage and Evaluation: Wear the B3 Buddy device Questionnaire Administration: Ancillary studies Walking: Walk approximately 90 feet | 0 | None | 0 | 21 | 0 | 21 | View |