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 |
|---|---|---|---|---|---|---|---|---|
| External Fixation | Adults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation. External fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery. | 0 | None | 0 | 1 | 0 | 1 | View |
| Splinting | Adults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation. Splinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery. | 0 | None | 0 | 0 | 0 | 0 | View |