Adverse Events Module

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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

Ignite Creation Date: 2025-12-24 @ 3:05 PM
Ignite Modification Date: 2025-12-25 @ 1:27 PM
NCT ID: NCT02807259
Description: A community advisory board of sex workers was set up to inform all aspects of study design, implementation and consent procedures, to ensure it was acceptable to the community and to help monitor any adverse events (defined as a report of sexual/physical violence). Outreach workers collected reports of violence during regular sessions with sex workers, completing a report when incidents occurred. These reports were monitored and reported to the Crisis Management Committee.
Frequency Threshold: 0
Time Frame: Data on adverse events were monitored for the duration of the intervention implementation (27 months).
Study: NCT02807259
Study Brief: Reducing Vulnerability in the Intimate Partnerships of Female Sex Workers Sex Workers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Multi-level Intervention At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours. 0 None 0 328 0 328 View
Control Peer educators, HIV counselling, condom distribution. The intervention will rolled out to all participating villages after 24 months. 0 None 0 292 0 292 View
Serious Events(If Any):
Other Events(If Any):