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: 2025-12-25 @ 2:46 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT03484533
Description: Social harms and pregnancy outcomes were recorded for the cohort, in addition to serious adverse events. We did not record death, SAEs, or Other AEs for male partners who were enrolled.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT03484533
Study Brief: HIV Self Testing of Male Partners of Women in PMTCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIV Self-test Kit: Female HIV self-test kit: We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART. 2 None 5 332 5 332 View
Invitation Letter-standard of Care: Female Standard of Care: In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART. 2 None 1 168 1 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Social Harm SYSTEMATIC_ASSESSMENT Social circumstances None View