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 |
|---|---|---|---|---|---|---|---|---|
| Usual Vocational Services + CBT | This is the experimental intervention - Usual vocational services at a vocational services center plus additional cognitive behavioral therapy at vocational service center. Vocational Services as usual plus Cognitive Behavioral Therapy (CBT): Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) | 0 | None | 0 | 120 | 0 | 120 | View |
| Usual Vocational Services | This is the care as usual intervention - Vocational services as usually delivered to service seeking clients Usual Vocational Services: Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads) | 0 | None | 0 | 130 | 0 | 130 | View |