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 |
|---|---|---|---|---|---|---|---|---|
| Fixed Bearing | P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base. | None | None | 1 | 49 | 0 | 49 | View |
| Rotating Platform | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. | None | None | 3 | 50 | 0 | 50 | View |