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 |
|---|---|---|---|---|---|---|---|---|
| Locked Set Screw | In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw with locking of the set screw. Locked Set Screw: Fixation of hip fracture with intramedullary hip screw with locking of the set screw | 0 | None | 0 | 0 | 0 | 0 | View |
| Unlocked Set Screw | In this arm, subjects who have sustained an intertrochanteric hip fracture (OTA classification A2 and A3) will undergo fixation with an intramedullary hip screw without locking of the set screw. Unlocked Set Screw: Fixation of hip fracture with intramedullary hip screw without locking of the set screw | 0 | None | 0 | 0 | 0 | 0 | View |