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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT03231358
Description: The definition of adverse events and serious adverse events is consistent with out this is defined on clinicaltrials.gov
Frequency Threshold: 0
Time Frame: We monitored any adverse events from enrollment of each participant, through study completion, approximately an average of 1 year in duration.
Study: NCT03231358
Study Brief: Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control - Parents Adolescents are the target participants for this study. Parents are assigned into an arm, based on the assignment of their child). Because parents are not the primary target of the study, more minimal information is collected on them. 0 None 0 444 0 444 View
Intervention - Adolescents Adolescents are the target participants for this study. Adolescent participants randomized to the behavioral intervention called "Our Family Our Future." These participants will receive an intervention to prevent sexually transmitted infections (STIs) including HIV, Chlamydia trachomatis and Neisseria gonorrhoeae; sexual risk behavior; and depression onset. This is a behavioral intervention, delivered in a group setting over 3-4 consecutive weeks. 0 None 0 435 0 435 View
Control - Adolescents Adolescents are the target participants of this study. Adolescents assigned to the control arm will receive usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care). 0 None 0 444 0 444 View
Intervention - Parents Adolescents are the target participants for this study. Parents are assigned into an arm, based on the assignment of their child). Because parents are not the primary target of the study, more minimal information is collected on them. 0 None 0 435 0 435 View
Serious Events(If Any):
Other Events(If Any):