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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT00805532
Description: None
Frequency Threshold: 0
Time Frame: 24 weeks
Study: NCT00805532
Study Brief: Behavioral Activation for PTSD/Depression Treatment in OIF/OEF 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
Behavioral Activation (BA) Behavioral Activation (BA)-BA is a present-focused, well-established treatment for depression that targets patterns of avoidance and involves the identification and enactment of activities that are reinforcing to the individual and consistent with his/her long-term goals. BA has been modified to address PTSD concerns in addition to depression and to be delivered in 6-8, 60-minute sessions. It was delivered by skilled psychotherapists. 0 None 5 42 3 42 View
Treatment as Usual (TAU) Participants randomized to Treatment as Usual (TAU) were referred for treatment within the PTSD Clinical Teams at the VAPORHCS and PSHCS. In both clinics providers are trained in Prolonged Exposure therapy (PE) and Cognitive Processing Therapy (CPT). Both clinics also offer skills-based "coping skills" treatments for PTSD and pharmacotherapy. Actual treatment received was determined collaboratively between the PTSD Clinic Care provider and veteran and could include any of these treatment options or combinations of treatments. 0 None 4 38 0 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
suicidal ideation with hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation with no hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
psychotic symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
discharging firearm NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
aggression with ER visit NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
homicidal ideation with crisis line call NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
very brief suicidal ideation, no hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
polymenorhea with hospitalization NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View