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 |
|---|---|---|---|---|---|---|---|---|
| Collaborative Care | Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy. Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians. | None | None | 0 | 92 | 0 | 92 | View |
| Usual Care | Patient's physicians are informed of diagnosis of depression/anxiety disorder Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis | None | None | 0 | 91 | 0 | 91 | View |