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 @ 12:28 AM
Ignite Modification Date: 2025-12-25 @ 10:35 PM
NCT ID: NCT04689867
Description: Systematic Assessment of Adverse Events: Routine determination of adverse events through standard assessment at each study timepoints by research staff, project coordinator, or principal investigator.
Frequency Threshold: 5
Time Frame: Adverse event data collected across participant involvement in study (beginning with the eligibility screener and ending after follow-up assessment): Approximately across 5 months per participant
Study: NCT04689867
Study Brief: Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CBSPp Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions. Cognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis. In this open pilot trial, all participants received the treatment. 0 None 0 5 1 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety during assessment SYSTEMATIC_ASSESSMENT Psychiatric disorders None View