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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT01109602
Description: None
Frequency Threshold: 5
Time Frame: 2 month period of the intervention
Study: NCT01109602
Study Brief: Strength, Flexibility, And Balance Therapy After Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1: Yoga Group Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises. None None 0 14 1 14 View
Arm 2: Yoga Group Plus Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results. Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises. None None 0 23 0 23 View
Arm 3: Wait List Control Group wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention. None None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View