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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT05208359
Description: 0 participants experiences all-cause mortality and serious adverse events. 1 participant experienced 1 other (not including serious) adverse event through self-disclosure from participant to research assistant during data collection.
Frequency Threshold: 0
Time Frame: 1 year, 7 months
Study: NCT05208359
Study Brief: Supporting Refugee and Immigrant Youth's Mental Health
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
STRONG Immediate Group Small mental health support group delivered immediately Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth 0 None 0 32 0 32 View
STRONG Delayed Group Small mental health support group delivered after a delay of approximately 3 months Supporting Transition Resilience Of Newcomer Groups (STRONG): 10 group sessions that offer skills, strengths, support, and affirmation for newcomer youth 0 None 0 32 1 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Endorsed risk and abuse NON_SYSTEMATIC_ASSESSMENT Social circumstances None View