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 @ 2:28 PM
Ignite Modification Date: 2025-12-25 @ 1:03 PM
NCT ID: NCT03115359
Description: Definitions from study protocol: 10.1.1 AE: Any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related. 10.1.2 SAE Any of the following: Fatal; life-threatening; persistent/significantly disabling/incapacitating; inpatient hospitalization/prolongation of hospitalization; significant medical incident that may jeopardize the participant and requires medical/surgical intervention to prevent one of the above outcomes
Frequency Threshold: 5
Time Frame: Adverse events were collected from enrollment through exit (12-month follow-up period) for each participant. Data on adverse events were systematically collected with a "negative side effects" survey at each assessment, and at each intervention session. In addition, study personnel inquired about potential adverse events at each participant contact. All adverse events were recorded, reported, and categorized according to the funding agency, IRB, and other regulatory guidance.
Study: NCT03115359
Study Brief: Strategies to Assist With Management of Pain
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 Based Therapy Mindfulness Based Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Mindfulness Based Therapy: The Mindfulness Based Therapy intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations. 1 None 0 385 0 385 View
Cognitive Behavioral Therapy Cognitive Behavioral Therapy intervention, adjunctive to usual care for opioid-treated chronic low back pain. Cognitive Behavioral Therapy: The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study. In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations. 3 None 0 385 24 385 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased pain reported as associated with progressive muscle relaxation exercise SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View