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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:01 AM
NCT ID: NCT01385202
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01385202
Study Brief: THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter None None 38 161 70 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CARDIAC TAMPONADE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEART BLOCK SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PAF ABLATION REDO SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERICARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VASOVAGAL SYNCOPE BECAUSE OF LEG CRAMPS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
DYSPHAGIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FEVER SYSTEMATIC_ASSESSMENT General disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Infections and infestations None View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations None View
VIRAL INFECTION RESULTING IN HOSPITALIZATION, PHLEBITIS FROM IV SYSTEMATIC_ASSESSMENT Infections and infestations None View
WBC ELEVATED, ABDOMINAL PAIN, ILEUS AND LOSS OF CAPTURE IN RV LEAD POST-LASER LEAD EXTRACT SYSTEMATIC_ASSESSMENT Infections and infestations None View
CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEFT KNEE INJURY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEFT ARM PAIN SYSTEMATIC_ASSESSMENT Nervous system disorders None View
LOC SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MIGRAINES SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
LUNG MASS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Vascular disorders None View
VASCULAR ACCESS COMPLICATIONS SYSTEMATIC_ASSESSMENT Vascular disorders None View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
AF SYSTEMATIC_ASSESSMENT Cardiac disorders None View
AFLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
AORTIC ROOT DILATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARRHYTHMIA -FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ARRYTHMIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FIBRILLATION RECURRENCE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FIBRILLATION, FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ATRIAL TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BILATERAL LOWER EXTREMITY EDEMA AND PAIN SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERICARDITIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERICARDIUM STAIN SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ADHESIVE CAPSULITIS OF SHOULDER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
EAR INFECTION SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
LEFT SHOULDER/ARM PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PARTIAL KNEE REPLACEMENT SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PINCHED NERVES SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
PLANTER FASCIITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
REPAIR OF BICEP TENDON SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
SYNOVIAL OSTEOCHONDROMATOSIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
UPPER SHOULDER/CERVICAL SPINE PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BENIGN TUMOR FOUND SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
HEADACHE WITH BLURRED VISION SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MIGRAINE HEADACHE WITH VISUAL FIELD LOSS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MIGRANE HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
PAIN, NUMBNESS -LEFT HAND/FINGERS LOSS OF STRENGTH SYSTEMATIC_ASSESSMENT Nervous system disorders None View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders None View
VASCULAR ACCESS COMPLICATIONS SYSTEMATIC_ASSESSMENT Nervous system disorders None View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
ONGOING EXERTIONAL SHORTNESS OF BREATH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SHORTNESS OF BREATH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
SOB AND BLOOD TRANSFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
BLEEDING GUMS SYSTEMATIC_ASSESSMENT Vascular disorders None View
HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders None View
POSSIBLE HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
RECTAL BLEEDING SYSTEMATIC_ASSESSMENT Vascular disorders None View
RIGHT GROIN HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
RT GROIN SEROMA/HEMATOMA SYSTEMATIC_ASSESSMENT Vascular disorders None View
SIDE EFFECTS FROM MEDICATION DOSING SYSTEMATIC_ASSESSMENT Vascular disorders None View
BREAKTHROUGH A-FIB SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIOVERSION FOR ATRIAL TACH SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
EXERTIONAL ANGINA SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HEART RACING, LIGHTHEADED, CHEST PAIN SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Cardiac disorders None View
HYPOTENSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NEAR-SYNCOPAL EPISODES SYSTEMATIC_ASSESSMENT Cardiac disorders None View
NEW DIAGNOSIS OF ATYPICAL ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PERICARDIAL EFFUSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RAPID ATRIAL FIB SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RAPID ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RECURRENCE AFIB REQUIRING CVS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RECURRENCE OF AF REQUIRING CARDIOVERSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RECURRENCE OF AFIB REQUIRING REPEAT ABLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RECURRENT AF REQUIRING CARDIOVERSION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
REPEAT PULMONARY VEIN ISOLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RIGHT SIDED ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders None View
STRONG HEART BEAT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VASOVAGAL EVENT SYSTEMATIC_ASSESSMENT Cardiac disorders None View
VOLUME OVERLOAD SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ADRENAL GLAND MASS SYSTEMATIC_ASSESSMENT Endocrine disorders None View
BLURRED VISION SYSTEMATIC_ASSESSMENT Eye disorders None View
BLURRY VISION, TINNITUS, HEADACHE SYSTEMATIC_ASSESSMENT Eye disorders None View
CHEST PAIN SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIAHRRHEA / STOMACH VIRUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DIARRHEA , GAS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GERD, TROUBLE SWALLOWING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
INTERMITTENT GASTRIC BURNING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
NEW ONSET DIABETES SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
STOMACH VIRUS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
FEVER SYSTEMATIC_ASSESSMENT General disorders None View
INCREASED TEMPERATURE SYSTEMATIC_ASSESSMENT General disorders None View
WASHED OUT FEELING SYSTEMATIC_ASSESSMENT General disorders None View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
HOSPITALIZATION, INTIAL AND PROLONGED SYSTEMATIC_ASSESSMENT Infections and infestations None View
SINUS INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
SINUSITIS/BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
UPPER RESPIRATORY INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
VIRAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations None View
FALL - DUE TO SLIP SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View