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 |
|---|---|---|---|---|---|---|---|---|
| Control - Standard Practice | Standard measures of quality as scheduled through One Care demonstration | 0 | None | 0 | 160 | 0 | 160 | View |
| Survey Arm | Consumer surveyed with Persons with Disabilities Quality Survey (PDQ-S) Results given to provider along with standard quality metric data as scheduled through One Care | 0 | None | 0 | 156 | 0 | 156 | View |
| YES Health | Initiative created by persons with disabilities for persons with disabilities to actively engage in collecting, analyzing and reporting on quality of care from the consumer perspective. The purpose is to engage eligible enrollees to answer brief surveys surrounding various themes about the care and experiences they receive through One Care. Subsequent brief, actionable reports are fed back to primary care provider practices randomized to this arm. YES Health: Intervention Arm | 0 | None | 0 | 135 | 0 | 135 | View |