Study: NCT02688153

Adverse event: Bleeding - cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 59 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: BLOOD SEPSIS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 59 at risk

Adverse event: BLEEDING - PERIPHERAL VASCULAR -MAJOR (E.G. NOSEBLEEDS; HEMATOMAS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: BLEEDING - GASTROINTESTINAL UPPER -MAJOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: BLEEDING - NEUROLOGICAL - MINOR (E.G. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 59 at risk

Adverse event: THROMBOEMBOLIC EVENT - OTHER - PERIPHERAL - NO PARESIS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ARRHYTHMIA - TACHYCARDIA - VENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: ANGINA, UNSTABLE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: CARDIAC DECOMPENSATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: HEART FAILURE - CHRONIC (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: PERICARDIAL EFFUSION - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: PERICARDIAL TAMPONADE - MAJOR
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 59 at risk

Adverse event: REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR-+4
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: NSD - PARAVALVULAR LEAK - +2
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 59 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 59 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 59 at risk

Adverse event: STERNAL WOUND/THORACIC INFECTION
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 59 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 59 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: VASCULAR - OTHER
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 59 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 59 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: RESPIRATORY FAILURE -OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: RESPIRATORY FAILURE -ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 59 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: RESPIRATORY DYSFUNCTION/INSUFFICIENCY
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: RESPIRATORY FAILURE -COPD
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 59 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 59 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 59 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 59 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 59 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 59 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: PERICARDIAL EFFUSION - MINOR
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 59 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 59 at risk

Adverse event: RENAL DYSFUNCTION
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 59 at risk

Adverse event: PSYCHIATRIC DISORDER
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 59 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: RESPIRATORY INFECTION - UPPER (URI)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 59 at risk

Adverse event: Bleeding - cardiovascular - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 61 at risk

Adverse event: Bleeding - Neurological - Major (e.g. CVA)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 61 at risk

Adverse event: ANEMIA - BLEEDING RELATED - MINOR
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL -MAJOR (E.G. ECCHYMOSIS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: BLEEDING - PERIPHERAL VASCULAR - MINOR (E.G. NOSEBLEEDS; HEMATOMAS)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 61 at risk

Adverse event: THROMBOEMBOLIC EVENT - STROKE
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 3RD DEGREE
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: ARRHYTHMIA - BRADYCARDIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: ANGINA, STABLE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: ANGINA, UNSTABLE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: CARDIAC DECOMPENSATION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: HEART FAILURE - ACUTE
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: HEART FAILURE - CHRONIC (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: CORONARY ARTERY OSTIAL OBSTRUCTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk

Adverse event: HYPERTENSION - SYSTEMIC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 61 at risk

Adverse event: GASTROINTESTINAL - INFECTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: GASTROINTESTINAL - OTHER
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 61 at risk

Adverse event: RENAL FAILURE - ACUTE
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 61 at risk

Adverse event: RENAL DYSFUNCTION
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: GENITOURINARY - OTHER
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 61 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 61 at risk

Adverse event: BONE FRACTURE/BREAK
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 61 at risk

Adverse event: CANCER - NEWLY DIAGNOSED
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: MULTI-SYSTEM ORGAN FAILURE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 61 at risk

Adverse event: VASCULAR - OTHER
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 61 at risk

Adverse event: PLEURAL EFFUSION - LEFT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: RESPIRATORY INFECTION - PNEUMONIA
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: PLEURAL EFFUSION - RIGHT
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: RESPIRATORY FAILURE -OTHER
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: ANEMIA - NON-BLEEDING RELATED
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 61 at risk

Adverse event: BLEEDING - CARDIOVASCULAR - MINOR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 61 at risk

Adverse event: ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 61 at risk

Adverse event: ARRHYTHMIA - AV BLOCK - 1ST DEGREE
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 61 at risk

Adverse event: ARRHYTHMIA - PERSISTANT ATRIAL FIBRILLAITON
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 61 at risk

Adverse event: CARDIOVASCULAR - OTHER
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 61 at risk

Adverse event: URINARY TRACT INFECTION (UTI)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 61 at risk

Adverse event: MUSCULAR SKELETAL / DERMATOLOGIC - OTHER
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 61 at risk