Study: NCT02672553

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: BLEEDING - GASTROINTESTINAL UPPER -MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: PERICARDIAL EFFUSION - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: PERICARDIAL TAMPONADE - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: CARDIAC DECOMPENSATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: NSD - PARAVALVULAR LEAK - +4
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: NSD - PARAVALVULAR LEAK WITH HEMOLYSIS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: BILIARY (GALLBLADDER)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: GENITOURINARY - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 49 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: RENAL - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 49 at risk

Adverse event: INFECTION /INFLAMMATION - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: MULTI-SYSTEM ORGAN FAILURE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: VASCULAR - OTHER
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 49 at risk

Adverse event: TRANSIENT PSYCHOTIC SYNDROME
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 49 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE -PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE -COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: PERICARDIAL EFFUSION - MINOR
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - GASTROINTESTINAL LOWER -MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - PULMONARY/RESPIRATORY MINOR (E.G. HEMOTHORAX)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLOOD/ LYMPHATIC - OTHER
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - ATRIAL FLUTTER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: NSD - PARAVALVULAR LEAK - +1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: INFECTION /INFLAMMATION - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: TRANSIENT PSYCHOTIC SYNDROME
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: PLEURAL EFFUSION - RIGHT
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: PULMONARY/RESPIRATORY - OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: RESPIRATORY FAILURE -COPD
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 48 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: PERICARDIAL TAMPONADE - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 48 at risk

Adverse event: CARDIAC DECOMPENSATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 48 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: REGURGITATION - MITRAL-INDETERMINATE-+4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: BILIARY (GALLBLADDER)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: RENAL DYSFUNCTION
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 48 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 48 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 48 at risk

Adverse event: ALLERGIC REACTION - MEDICATION RELATED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: TRANSIENT PSYCHOTIC SYNDROME
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: RESPIRATORY FAILURE -PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: RESPIRATORY FAILURE -COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 48 at risk

Adverse event: ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 48 at risk

Adverse event: PERICARDIAL EFFUSION - MINOR
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 48 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 48 at risk

Adverse event: PLEURAL EFFUSION - BILATERAL
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 48 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 48 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 48 at risk

Adverse event: THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 2ND DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLATION
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 48 at risk

Adverse event: GENITOURINARY - OTHER
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 48 at risk

Adverse event: WOUND INFECTION - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: TRANSIENT PSYCHOTIC SYNDROME
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 48 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: PLEURAL EFFUSION - RIGHT
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: RESPIRATORY FAILURE -OTHER
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 48 at risk