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 |
|---|---|---|---|---|---|---|---|---|
| Unicirc With Tissue Adhesive | Excision of foreskin with Unicirc device and sealing wound with tissue adhesive Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive | None | None | 0 | 50 | 4 | 50 | View |
| Surgical Control | Surgical circumcision using forceps guided, dorsal slit, or sleeve method Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions. | None | None | 0 | 50 | 9 | 50 | View |