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 |
|---|---|---|---|---|---|---|---|---|
| Dystonia Severity Assessment | We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline. Boston Scientific Vercise PC IPG with directional DBS lead: We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD. | 0 | None | 0 | 38 | 0 | 38 | View |