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 |
|---|---|---|---|---|---|---|---|---|
| Individual Placement and Support | Individual Placement and Support (IPS) is a well-defined intervention aiming to help people with disabilities participate in the competitive labor market by working in jobs they prefer with the professional help that they need. IPS actively facilitates job acquisition and provides ongoing support once the client is employed. Individual Placement and Support | 2 | None | 0 | 227 | 0 | 227 | View |
| Ordinary Employment Schemes | The control group will receive treatment as usual in terms of the ordinary employment schemes offered to this group, primarily Work with assistance and/or Traineeship in a sheltered business. Ordinary employment schemes | 0 | None | 0 | 181 | 0 | 181 | View |