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 @ 4:50 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT03875950
Description: None
Frequency Threshold: 0
Time Frame: 18 months from initiation of the training intervention
Study: NCT03875950
Study Brief: Standardized Patient Encounters to Improve PrEP Counseling for Adolescent Girls and Young Women in Kenya
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care Control In this randomized cluster randomized control trial design, the no intervention arm refers to the 12 study sites that are randomly assigned not to receive the clinician training intervention. Instead, these study sites will receive the standard of care, which is no standardized patient actor training, for health care workers who deliver PrEP to adolescent girls and young women to prevent HIV. 0 None 0 107 0 107 View
Training Intervention In this cluster randomized control trial design, the experimental arm refers to the 12 study sites that are randomly assigned to receive the clinician training intervention. The intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care workers who deliver PrEP to adolescent girls and young women to prevent HIV. Clinician training intervention: This intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care workers delivering PrEP to adolescent girls and young women to prevent HIV in Kenya. 0 None 0 125 0 125 View
Serious Events(If Any):
Other Events(If Any):