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 |
|---|---|---|---|---|---|---|---|---|
| Fracture Reduction Without Ultrasound | Fracture reduction as per standard of care involves closed fracture reduction without real-time imaging, or with c-arm or portable x-ray. Closed reduction of a fractured bone. Closed reduction is a procedure to set (reduce) a broken bone without surgery. This allows the bone to grow back together. It works best when it is done as soon as possible after the bone breaks. Standard of care fracture reduction: Closed reduction of a fractured bone. | 0 | None | 0 | 2 | 0 | 2 | View |
| Fracture Reduction With Ultrasound | Ultrasound guided Fracture reduction involves closed fracture reduction with the use of real-time ultrasound imaging, prior to, during and after the reduction procedure. C-arm or portable x-ray may also be used as an adjunct. Ultrasound - guided fracture reduction: Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction. Standard of care fracture reduction: Closed reduction of a fractured bone. | 0 | None | 0 | 2 | 0 | 2 | View |