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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT02283333
Description: Adverse events and serious adverse events were recorded in accordance with clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for a period of 5 years, 1 month.
Study: NCT02283333
Study Brief: Treatment of Prolonged Grief Disorder in Combat Veterans
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BATE-G Behavioral Activation and Therapeutic Exposure - Grief therapy are delivered in 7 weekly sessions to the participant. BATE-G: Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant. 0 None 0 77 0 77 View
Standard Treatment Cognitive Restructuring and Supportive Grief Counseling are delivered in 7 weekly sessions to the participant. Standard Treatment: Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant. 0 None 1 78 0 78 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Serious Adverse Event NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):