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 |
|---|---|---|---|---|---|---|---|---|
| Enhanced Standard of Care | PrEP education and referral to a community-based PrEP provider (enhanced standard of care) Enhanced Standard of Care: Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive. | 0 | None | 0 | 50 | 0 | 50 | View |
| Community Health Worker Involved Enhanced Standard of Care | PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services. PrEP-LINK: CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network \[TCN\]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence. | 0 | None | 0 | 50 | 0 | 50 | View |