Study: NCT01651052

Adverse event: Anemia - non-bleeding related
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Angina, stable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia-AV block III
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - AV block - 3rd degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Arrhythmia - bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - paroxysmal atrial fibrillation (PAF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 133 at risk

Adverse event: Arrhythmia - persistent atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Arrhythmia - supraventricular tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - tachy-bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Biliary (gallbladder)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Bleeding event
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 133 at risk

Adverse event: Bone fracture/break
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 133 at risk

Adverse event: Cancer - newly diagnosed
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 133 at risk

Adverse event: Cancer - progression of underlying disease
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 133 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Cardiac decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Cardiovascular - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Cardiovascular - other --> infection inflammation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Endocrine complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 133 at risk

Adverse event: Gastrointestinal - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 133 at risk

Adverse event: Genitourinary - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 133 at risk

Adverse event: Heart failure - chronic (CHF)
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Hypertension - systemic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Muscular skeletal / dermatologic - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 133 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nonspecific, unknown or other body system - other complication
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pancreatic complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pericardial effusion - major
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pericardial effusion - minor
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pericardial tamponade - major
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 133 at risk

Adverse event: Pleural effusion - bilateral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pleural effusion - left
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Pleural effusion - right
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pulmonary/respiratory - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Renal - other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Renal dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Renal failure - acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 133 at risk

Adverse event: Renal failure - chronic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Respiratory dysfunction/insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Respiratory failure - pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Respiratory infection - pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Respiratory infection - upper
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Sternal wound/thoracic infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 133 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Tachy-bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 133 at risk

Adverse event: Transient psychotic syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 133 at risk

Adverse event: Valve thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 133 at risk

Adverse event: Vision disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Wound infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - AV block - 1st degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - paroxysmal atrial fibrillation (PAF)
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 133 at risk

Adverse event: Arrhythmia - paroxysmal atrial tachycardia (PAT)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - permanent atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Arrhythmia - persistent atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Arrhythmia - tachy-bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Bleeding event
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Cardiovascular - other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Non structural valve dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Nonspecific, unknown or other body system - other complication
Serious: no
Organ System: General disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pericardial effusion - minor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pleural effusion - right
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 133 at risk

Adverse event: Renal dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 133 at risk

Adverse event: Respiratory infection - upper
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Stenosis - tricuspid - moderate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Transient psychotic syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 133 at risk

Adverse event: Vision disorder
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 133 at risk