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 @ 11:08 PM
Ignite Modification Date: 2025-12-25 @ 8:41 PM
NCT ID: NCT04408469
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored from baseline through completion of the final follow-up assessment at 8 months.
Study: NCT04408469
Study Brief: A Trial of Online LGBTQ-affirmative Cognitive Behavioral Therapy to Reduce Depression and Associated Health Risks Among Young Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Self-Monitoring Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks Self-monitoring control: Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks 0 None 1 60 0 60 View
Online EQuIP The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. Online EQuIP: This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks. 0 None 0 60 1 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Active Suicidality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View