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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Services as Usual | Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. Services as Usual: Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. | 0 | None | 0 | 23 | 0 | 23 | View |
| Services as Usual + Virtual Reality Job Interview Training | In addition to the services as usual comparator, participants will participate in Virtual Reality Job Interview Training. Virtual Reality Job Interview Training: Students will engage in didactic training related to strategies to perform well during a job interview as well as repeated practice with a virtual hiring manager. Throughout and after completion of the virtual interviews, participants will receive feedback on their performance. Services as Usual: Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training. | 0 | None | 0 | 48 | 0 | 48 | View |