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 @ 5:36 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
NCT ID:
NCT04133168
Description:
None
Frequency Threshold:
0
Time Frame:
Through 12 Months
Study:
NCT04133168
Study Brief:
Boston Scientific's Cryoballoon in the Treatment of Symptomatic Drug Refractory 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 |
|---|---|---|---|---|---|---|---|---|
| FROzEN Non Roll In Treatment and Attempt Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories | 1 | None | 33 | 326 | 86 | 326 | View |
| FROzEN Roll In Treatment Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories | 1 | None | 10 | 60 | 16 | 60 | View |
| POLARx FIT Treatment Subjects | Subjects undergoing cardiac ablation procedure with the Boston Scientific Cardiac Cryoablation System Boston Scientific Cardiac Cryoablation System: The Boston Scientific Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The main devices and components of the system consists of the following: * POLARx™ or POLARx FIT Cryoablation Catheter * POLARMAP™ Catheter * POLARSHEATH™ * SMARTFREEZE™ Console * Diaphragm Movement Sensor (DMS) * Related Accessories | 0 | None | 4 | 50 | 5 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina/ chest pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Edema | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain-other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever and/or virus | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Integumentary | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Atrial Tachycardia/ Other SVT (e.g. AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Peripheral vascular disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Abnormal lab values | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cancer | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Physical Trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| 1st Degree AV block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atypical (Type II) Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Tachycardiac (VT)/ Monomorphic VT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertensive/ Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| COPD Exacerbation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Vasovagal Reaction | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial (Type I) Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Chest pain- other | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Conduction pathway injury | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertension/ Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypotension/ Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Multiple symptoms | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Sinus Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Ventricular Tachycardia (VT)/ Monomorphic VT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fever and/or virus | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Head, Eyes, Ears, Nose, Throat (HEENT) | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Physical Trauma | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Renal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Procedure related Anesthesia/ sedation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Atrial tachycardia/ Other SVT (e.g AVRT, AVNRT, EAT) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Localized infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Psychological | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Angina/ chest pain | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Atrial Flutter (not specified) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Bleeding related to anticogulation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Edema | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Embolism - air | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Gasteroparesis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hematoma | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Oozing/ bleeding | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pain (non-cardiovascular) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Phrenic Nerve Injury temporary | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pleuritis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post procedure infection/ Sepsis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Post procedure wound discomfort | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related allergic reactions/ adverse drug reaction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related anesthesia/ sedation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Pulmonary Edema | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Right atrial (type 1) atrial flutter | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Procedure related Pulmonary (including cough, hemoptysis) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Premature atrial contractions (PAC) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Ablation induced Arrhythmia | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Myocardial Perforation with tamponade | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related gastrointestinal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related hypertension | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Procedure related Neurological (non-TIA, non-stroke, dysphagia, speech disturbance/ dysarthria) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |