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 @ 6:41 PM
Ignite Modification Date: 2025-12-25 @ 4:12 PM
NCT ID: NCT01087957
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01087957
Study Brief: WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
WalkAide Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) None None 18 242 162 242 View
Ankle-Foot Orthosis (AFO) Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO) None None 17 253 146 253 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Death SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Death SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac disorder SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Back surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
TIA or CVA SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Renal failure/infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hospitilization GI disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitilized for abnormal Blood Sugar level SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Falls SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in back or Lower Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue/Muscle weakness SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Other medical conditions SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View