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 |
|---|---|---|---|---|---|---|---|---|
| Treatment-Enhanced Services (Standard + Ray of Hope) | Treatment group participants receive standard and enhanced services. Standard services are delivered as primary services to participants in both study groups under a shared condition, and they are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. Finally, only the treatment group receives 10 hours of the Ray of Hope curriculum as an enhanced service. Optional services are available to both study groups by selecting 1-3 hours of coursework from a menu of courses in the Mini-Clinic that address a variety of needs. Standard Servies + Ray of Hope Curriculum: Standard services delivered as primary services to participants in both study groups under a shared condition are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. Optional services available to both study groups by selecting 1-3 hours of coursework from menu of courses that address a variety of needs. Standard Services: Standard services delivered as primary services to participants in both study groups under a shared condition are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. | 0 | None | 0 | 382 | 0 | 382 | View |
| Control-Standard Services | Only standard services are delivered to participants in the control group under a shared condition with the treatment group, and they are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. Optional services are available to both study groups by selecting 1-3 hours of coursework from a menu of courses that address a variety of needs. Standard Services: Standard services delivered as primary services to participants in both study groups under a shared condition are: 20 hours of TYRO Dads curricula and 6 hours of Core Communication curricula. | 0 | None | 0 | 366 | 0 | 366 | View |