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 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:08 AM
NCT ID: NCT03952520
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected for HIV Test Site Directors and Staff and the longitudinal subsample cohort of PWID from the time of signing informed consent until the respective site at which the participant was enrolled reached implementation Month 24, up to approximately 24 months. Adverse events were collected for PWID participants not in the longitudinal subsample cohort from the time of signing informed consent until the completion of intervention activities, up to approximately 8 weeks.
Study: NCT03952520
Study Brief: Scaling up an Evidence-based Intervention for Antiretroviral Therapy for PWID in Vietnam: an Implementation Trial
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 Approach (SA) PWID PWID enrolled at clinics implementing SNaP under the Standard Approach. 23 None 0 359 0 359 View
Tailored Approach (TA) PWID PWID enrolled at clinics implementing SNaP under the Tailored Approach. 42 None 0 364 0 364 View
Standard Approach (SA) HIV Test Site Directors and Staff HIV Test Site Directors and Staff working at clinics implementing SNaP under the Standard Approach. 0 None 0 136 0 136 View
Tailored Approach (TA) HIV Test Site Directors and Staff HIV Test Site Directors and Staff working at clinics implementing SNaP under the Tailored Approach. 0 None 0 141 0 141 View
Serious Events(If Any):
Other Events(If Any):