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 @ 4:56 AM
Ignite Modification Date: 2025-12-26 @ 3:56 AM
NCT ID: NCT02494518
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks from baseline assessment
Study: NCT02494518
Study Brief: Forced Aerobic Exercise for Stroke Rehabilitation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Forced Exercise & Upper Extremity Repetitive Task Practice Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises Forced Exercise \& Upper Extremity Repetitive Task Practice 0 None 0 11 1 11 View
Voluntary Exercise & Upper Extremity Repetitive Task Practice Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises Voluntary Exercise \& Upper Extremity Repetitive Task Practice 0 None 0 12 0 12 View
Stroke Education & Upper Extremity Repetitive Task Practice Participants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises Stroke Education \& Upper Extremity Repetitive Task Practice 0 None 1 11 0 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin Integrity NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View