Study: NCT02907463

Adverse event: Anemia - Bleeding related - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 1st degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 2nd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 280 at risk

Adverse event: Arrhythmia - Atrial Flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 280 at risk

Adverse event: Arrhythmia - Permanent Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Persistent Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 280 at risk

Adverse event: Arrhythmia - Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Arrhythmia - Tachy-Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Ventricular Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Biliary (Gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 280 at risk

Adverse event: Bleeding - Gastrointestinal Lower - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Gastrointestinal Upper - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Gastrointestinal Upper - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Neurological - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bone Fracture / Break
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cancer - Newly diagnosed
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cancer - Progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 280 at risk

Adverse event: Chordae tendineae damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Deep Sternal Wound / Thoracic Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 280 at risk

Adverse event: Fever - Unknown Origin
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 280 at risk

Adverse event: Gastrointestinal - Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 280 at risk

Adverse event: Hearing disorder
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 280 at risk

Adverse event: Heart Failure - Acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 280 at risk

Adverse event: Heart Failure - Chronic (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Infection / Inflammation - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 280 at risk

Adverse event: Multi-System organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Muscular Skeletal / Dermatologic - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 280 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: NSVD - LVOT damage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: NSVD - Paravalvular Leak - +2
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Nonspecific, Unknown, or Other Body System - Other complication
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 280 at risk

Adverse event: Pancreatic complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Perforation - Atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Pericardial Effusion - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 280 at risk

Adverse event: Pericardial Effusion - Minor
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 280 at risk

Adverse event: Pleural Effusion - Bilateral
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Pleural Effusion - Left
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 280 at risk

Adverse event: Pleural Effusion - Right
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 280 at risk

Adverse event: Psychiatric - Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 280 at risk

Adverse event: Psychiatric Disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 280 at risk

Adverse event: Pulmonary Embolism - Right
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Renal Dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Renal Failure - Acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 280 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory Failure - COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 280 at risk

Adverse event: Respiratory Failure - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory Failure - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory Infection - Lower (Bronchitis)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 280 at risk

Adverse event: Respiratory Infection - Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 280 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Splenic complication
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Sudden, Unexplained Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 280 at risk

Adverse event: Superficial Wound Infection - Sternal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 280 at risk

Adverse event: Thromboembolic Event - Other - Central - Hemiparesis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Thromboembolic Event - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 280 at risk

Adverse event: Transient Psychotic Syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 280 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Vascular - Access Site Complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Anemia - Bleeding related - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 280 at risk

Adverse event: Anemia - Non-bleeding related
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 280 at risk

Adverse event: Angina, Stable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 2nd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - AV Block - 3rd degree
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: Arrhythmia - Atrial Flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 53 affected / 280 at risk

Adverse event: Arrhythmia - Bundle Branch Block - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 280 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 57 affected / 280 at risk

Adverse event: Arrhythmia - Paroxysmal Atrial Tachycardia (PAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Persistent Atrial Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 280 at risk

Adverse event: Arrhythmia - Tachy-Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Arrhythmia - Tachycardia - Non-Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Arrhythmia - Tachycardia - Ventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 280 at risk

Adverse event: Arrhythmia - Ventricular Fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Cardiovascular - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Genitourinary - Major
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Bleeding - Genitourinary - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 280 at risk

Adverse event: Bleeding - Musculoskeletal/Dermatological - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 280 at risk

Adverse event: Bleeding - Pulmonary/Respiratory Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Blood/ Lymphatic - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 280 at risk

Adverse event: Bone Fracture / Break
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Endocrine complications
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 280 at risk

Adverse event: Fever - Unknown Origin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 280 at risk

Adverse event: Gastrointestinal - Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 280 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 280 at risk

Adverse event: Hepatic complication - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hypertension - Pulmonary
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hypertension - Systemic
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 280 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Infection / Inflammation - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 280 at risk

Adverse event: Metabolic complications
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 280 at risk

Adverse event: Muscular Skeletal / Dermatologic - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 280 at risk

Adverse event: NSVD - Paravalvular Leak - +1
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 280 at risk

Adverse event: NSVD - Paravalvular Leak - +2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Nonspecific, Unknown, or Other Body System - Other complication
Serious: no
Organ System: General disorders
Frequency: 5 affected / 280 at risk

Adverse event: Pericardial Effusion - Minor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Pleural Effusion - Bilateral
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 280 at risk

Adverse event: Pleural Effusion - Left
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 280 at risk

Adverse event: Pleural Effusion - Right
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 280 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 280 at risk

Adverse event: Psychiatric - Other
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 280 at risk

Adverse event: Psychiatric Disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 280 at risk

Adverse event: Pulmonary/Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Regurgitation - Aortic-Central/Transvalvular-+1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 280 at risk

Adverse event: Renal Dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 280 at risk

Adverse event: Renal Failure - Acute
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 280 at risk

Adverse event: Respiratory Infection - Lower (Bronchitis)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory Infection - Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 280 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Superficial Wound Infection - Sternal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 280 at risk

Adverse event: Thrombocytopenia - Heparin Induced (HIT)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 280 at risk

Adverse event: Transient Psychotic Syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 280 at risk

Adverse event: Urinary Tract Infection (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 280 at risk

Adverse event: Vascular - Access Site Complication
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Vascular - Other
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Wound Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 280 at risk