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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:15 PM
NCT ID: NCT02524158
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02524158
Study Brief: Yoga for Veterans With CLBP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Yoga The yoga intervention consisted of 2x weekly, 60-minute Hatha Yoga classes for 12 weeks, geared toward a CLBP population. Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose. 0 None 0 75 2 75 View
Delayed Treatment Control - Usual Care Participants randomly assigned to this arm are allowed to continue all existing treatments. Participants and their primary care physician are asked to not change treatments unless medically necessary. participants are asked to not do yoga for 6 months. They are given free yoga and a yoga mat after 6 months. 0 None 0 75 0 75 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View