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 @ 12:37 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT05168267
Description: Since this is a mental health study, our definition of an adverse event slightly differs from ClinicalTrials.gov definitions. If the participant exhibits any negative/significant psychological symptoms, social issues, physical injuries, medical injuries, or other negative life events, this is considered an adverse event.
Frequency Threshold: 0
Time Frame: Adverse events were collected from consented (one week prior to intervention) to the three month follow up (12 weeks after intervention, up to 25 weeks total)
Study: NCT05168267
Study Brief: PTSD Treatment for Incarcerated Men and Women: NIMH
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Women's Facility Cognitive Processing Therapy (CPT) Arm = Cognitive Processing Therapy (CPT) Group = Womens Facility: 6 groups of 4-6 (35 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. 0 None 0 35 7 35 View
Men's Facility Cognitive Processing Therapy (CPT) Arm = Cognitive Processing Therapy (CPT) Group = Mens Facility: 6 groups of 4-6 (34 total) receive CPT to treat PTSD Cognitive Processing Therapy: CPT: a type of cognitive behavioral therapy recommended for the treatment of PTSD. Delivered over 12 sessions with an emphasis on addressing trauma-related cognitions and challenging trauma-related beliefs. Includes worksheet assignments. For this study, CPT will be conducted in groups. 0 None 0 34 14 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Passive Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased PTSD symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increase in depressive symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical Event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased emotional distress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Segregated Housing Placement / Rule Violation NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Social Circusmtances NON_SYSTEMATIC_ASSESSMENT Social circumstances None View