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 |
|---|---|---|---|---|---|---|---|---|
| Measurement Based Care Implementation | Four community mental health clinics located in Washington state will receive trainings on how to implement Measurement Based Care (MBC) in their clinics. We co-created implementation plans to improve therapists' use of measurement-based care by (1) identifying barriers and facilitators to MBC, (2) prioritizing barriers, and (3) co-developing an implementation strategy. The primary outcome of interest was whether the co-developed implementation strategies improved clinician's use of MBC (defined as % of youth clients administered measures) with youth clients. NOTE: Patients/clients were not enrolled in outcome measurement, as the study was primarily focused on whether implementation strategies improved clinicians use of measurement-based care (i.e., clinicians were the primary unit of analysis). | 0 | None | 0 | 76 | 0 | 76 | View |