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 @ 2:43 PM

Ignite Modification Date: 2025-12-25 @ 1:13 PM

NCT ID: NCT00538759

Description: None

Frequency Threshold: 5

Time Frame: Adverse events were collected out to two years

Study: NCT00538759

Study Brief: Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

EBRT	External beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty. External beam radiation therapy: Experimental beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty	8	None	12	13	13	13	View
Control	Sham external beam radiation therapy to the aortic valve after successful balloon aortic valvuloplasty.	3	None	7	8	8	8	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Anemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Arrhythmia	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Aortic Valve Replacement	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Balloon Valvuloplasty	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bleed	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Cancer	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Congestive Heart Failure Exacerbation	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Dehydration	NON_SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Fatigue/Weakness	NON_SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Hepatic Ischemia	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Hypoglycemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypokalemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hyponatremia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypotension	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Multi-system Organ Failure	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-cardiac Chest Pain	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pneumonia	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneaumothorax	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Acute Renal Failure	NON_SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Respiratory/COPD	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Aortic Valve Restenosis	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Vertebraplasty	NON_SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Dyspnea	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Edema	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Fatigue/Weakness	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Non-Cardiac Chest Pain	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Abrasion	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Aches	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Anemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Arrhythmia	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Atrial Enlargement	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Bleed	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Bone Fracture	NON_SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Cardiomegaly	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Congestive Heart Failure	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Constipation/Fecal Impaction	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Chest Pain/Angina	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Cramping	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Dehydration	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Diaphoresis	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Diarrhea	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dizzy/Lightheaded	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Ecchmyosis	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Fever	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Groin Pain	NON_SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Headache	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Heart Murmur	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ulcer	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Hematoma	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hemoptysis	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hyperglycemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hyperkalemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypertension	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypoglycemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypokalemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypomagnesemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypotension	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Hypoxemia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Inflamation	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View
Knee Replacement	NON_SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Leukocytosis	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Luekopenia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Mental Status Change	NON_SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Urinary Issues	NON_SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary Tract Infection	NON_SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Orthostatic Hypotension	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Palpitations	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pulmonary Embolism	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pacemaker Generator Change	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Pneumonia	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Respiratory/COPD	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Sinus Infection	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hyperdense Renal Lesions	NON_SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Thrombocytopenia	NON_SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Upset Stomach/Vomit	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Worsening Aortic Stenosis	NON_SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Decreased Motor Function	NON_SYSTEMATIC_ASSESSMENT	General disorders	None	View