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 |
|---|---|---|---|---|---|---|---|---|
| Pre-implementation | The pre-implementation cohort includes data from 5000 HIV primary care clinic patients in Kaiser Permanente Northern California, who receive services prior to implementation of computerized screening and behavioral intervention in the clinics. | 0 | None | 0 | 5706 | 0 | 5706 | View |
| Post-implementation | The post-implementation cohort includes data from 5000 HIV primary care clinic patients in Kaiser Permanente Northern California, who receive services after computerized screening and behavioral intervention have been implemented in the clinics. Clinic-based screening and behavioral interventions: As part of routine HIV primary care visits, patients will complete self-administered computerized substance use, anxiety and depression screening measures. Results will be integrated into the electronic health record. A behavioral health specialist on the clinic staff will contact patients who screen positive for high-risk substance use, anxiety or depression, and offer behavioral interventions including motivational interviewing and cognitive behavioral therapy. | 0 | None | 0 | 5115 | 0 | 5115 | View |