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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:16 PM
NCT ID: NCT01022203
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01022203
Study Brief: Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PTSD Family Education (PFE) Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment. PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included. None None 0 56 2 56 View
Structured Approach Therapy (SAT) Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD. Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication. None None 0 58 0 58 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Domestic violence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Domestic violence. View