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 |
|---|---|---|---|---|---|---|---|---|
| Cultural Adaptation of a Client-Provider Communication Tool | The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted client-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled participant took part in a pilot study evaluating the client-provider communication tool adapted for PrEP uptake among Black or African American cis-gender women and their healthcare providers in a pre-post intervention design. Eligibility criteria was expanded to include women of any race/ethnicity. Participating healthcare providers discussed PrEP with participants using the communication tool. | 0 | None | 0 | 67 | 0 | 67 | View |