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 @ 4:55 PM
Ignite Modification Date: 2025-12-25 @ 2:38 PM
NCT ID: NCT04129450
Description: Adverse Event: any untoward medical occurrence (whether physical or psychological) associated with the use of meditation or mind and body methods, or breach of confidentiality and which may have a causal relationship with the study procedures. This definition is more specific to breach of confidentiality and any issues related to meditation practices.
Frequency Threshold: 0
Time Frame: Adverse events were collected from participants over a 12-month period, which corresponded to the duration of their participation in the study.
Study: NCT04129450
Study Brief: Group-based Mindfulness for Chronic Pain in the Primary Care Setting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mindfulness Pain Program + Usual PCP Care Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. Group medical visits with mindfulness-based stress reduction: Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits Usual PCP care: Usual one on one PCP care for chronic lower back pain 0 None 0 224 4 224 View
Usual PCP Care Participants will receive usual PCP care for chronic lower back pain. Usual PCP care: Usual one on one PCP care for chronic lower back pain 0 None 0 227 0 227 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sciatic Pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View