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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 | 3 patients with mandibular fracture(s) who underwent surgical repair at San Francisco VA Medical Center Surgical repair of mandibular fracture(s): Patients will undergo whatever needed surgical repair of mandibular fracture(s) that is necessary. Records such as CT imaging were utilized in the standard way to plan and carry out the surgery. The CT scan was also used within the visuohaptic computational environment to develop and evaluate the user interface. | None | None | 0 | 3 | 0 | 3 | View |