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: 2025-12-26 @ 11:49 AM
Ignite Modification Date: 2025-12-26 @ 11:49 AM
NCT ID: NCT05524116
Description: The adverse events were self-reported by participants during the course of the study. No serious adverse events were reported by participants in either groups.
Frequency Threshold: 0
Time Frame: 14-weeks
Study: NCT05524116
Study Brief: Telehealth Exercise and Mindfulness for Pain in Osteoarthritis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group TX (Telehealth Exercise) Participants in this group will receive a supervised and group-based exercise program once a week for 8 weeks via telehealth. Exercise: In this 8-week intervention, participants will be given recommended strengthening and neuromuscular exercises for knee osteoarthritis. Participants in both the intervention and control group will receive these exercises. 0 None 0 19 8 19 View
Group TMX (Telehealth Exercise and Mindfulness) Participants in this group will receive a supervised, group-based integrated mindfulness and exercise program once a week for 8 weeks via telehealth. Mindful Exercise program: In this 8-week intervention, components of Mindful Based Stress Reduction Program will be integrated with strengthening and neuromuscular exercises recommended for knee osteoarthritis. The goal of this program is to train participants how to be mindful during their exercises. 0 None 0 21 3 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hernia surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ankle injury NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Knee replacement surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Generally feeling unwell NON_SYSTEMATIC_ASSESSMENT General disorders None View
Exacerbation of knee pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View