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 |
|---|---|---|---|---|---|---|---|---|
| PureWick Male External Catheter | PureWick Male External Catheter: The PureWick⢠Male External Catheter (MEC) is intended for non-invasive urine output management in male patients. It is a single-use, non-sterile device. The PureWick⢠Male External Catheter is a commercially available device which is Class I, 510(K) exempt. | 0 | None | 0 | 59 | 0 | 59 | View |
| Sage PrimoFit | Sage PrimoFit: The PrimoFit External Urine Management for the Male Anatomy is indicated for the non-invasive external collection of urine for adult patients with male anatomy who require urine management. It is a single-use, non-sterile device. The Sage PrimoFit is a commercially available device which is Class I, 510(K) exempt. | 0 | None | 0 | 59 | 0 | 59 | View |