Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 7:22 PM
Ignite Modification Date: 2025-12-25 @ 5:02 PM
NCT ID: NCT02755103
Description: None
Frequency Threshold: 5
Time Frame: Approximately 8-9 months
Study: NCT02755103
Study Brief: Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
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 Receiving TAU Women will only receive treatment as usual (TAU less trauma focused group). 1 None 3 45 20 45 View
Women Receiving MBRP Plus TAU Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). Mindfulness Based Relapse Prevention (MBRP): MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. 0 None 4 45 28 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Knee Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
alcohol poisening SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Physical Assault SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
gall bladder stones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Severe opioid withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cold SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Teeth Decay SYSTEMATIC_ASSESSMENT Infections and infestations None View