Study: NCT01171625

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 258 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 258 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 87 affected / 258 at risk

Adverse event: Bleeding - Major
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 258 at risk

Adverse event: Bleeding - Minor
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 258 at risk

Adverse event: Bone Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 258 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 258 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Cardiac Conduction Disturbance
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 258 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 258 at risk

Adverse event: Cardiovascular - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 258 at risk

Adverse event: Cardiovascular Dissection / Tear / Injury
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 258 at risk

Adverse event: Oedema
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 258 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 258 at risk

Adverse event: Fever - Unknown Origin
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 258 at risk

Adverse event: Gastro-Intestinal Complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 258 at risk

Adverse event: Hematological Disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 258 at risk

Adverse event: Hepatic Complication
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 258 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Infection / Inflammation
Serious: yes
Organ System: Infections and infestations
Frequency: 40 affected / 258 at risk

Adverse event: Metabolic Complication
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 258 at risk

Adverse event: Mitral Regurgitation (Native)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 258 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 258 at risk

Adverse event: NSVD - Other non-structural valve dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: NSVD - Paravalvular Leak - Major
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: NSVD - Paravalvular Leak - Minor
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 8 affected / 258 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 63 affected / 258 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 258 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 37 affected / 258 at risk

Adverse event: Pneumothorax / Hemothorax
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Psychiatric Complication
Serious: yes
Organ System: Psychiatric disorders
Frequency: 6 affected / 258 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 258 at risk

Adverse event: Renal Complication
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 258 at risk

Adverse event: Respiratory Complication
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 258 at risk

Adverse event: SVD - Other structural valve deterioration
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 258 at risk

Adverse event: SVD - Study valve calcification
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 258 at risk

Adverse event: Sternal / Thoracic Wound Complication
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 258 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 258 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Thromboembolism - Non-cerebral
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Thromboembolism - Stroke
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 258 at risk

Adverse event: Thromboembolism - TIA
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 258 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 258 at risk

Adverse event: Vascular Complication
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 258 at risk

Adverse event: Vision Disorder
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 258 at risk

Adverse event: Abnormal Lab Values
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 258 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 258 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 258 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 258 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: Bleeding - Minor
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 258 at risk

Adverse event: Bone Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 258 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: General disorders
Frequency: 4 affected / 258 at risk

Adverse event: Cardiac Conduction Disturbance
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 258 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Cardiovascular - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 258 at risk

Adverse event: Drug Reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 258 at risk

Adverse event: Oedema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 258 at risk

Adverse event: Fever - Unknown Origin
Serious: no
Organ System: General disorders
Frequency: 5 affected / 258 at risk

Adverse event: Gastro-Intestinal Complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 258 at risk

Adverse event: Hematological Disorder
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 258 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: Hepatic Complication
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 258 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Infection / Inflammation
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 258 at risk

Adverse event: Metabolic Complication
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 258 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 258 at risk

Adverse event: NSVD - Paravalvular Leak - Minor
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 84 affected / 258 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 258 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 258 at risk

Adverse event: Pneumothorax / Hemothorax
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 258 at risk

Adverse event: Psychiatric Complication
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 258 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Renal Complication
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 258 at risk

Adverse event: Respiratory Complication
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 258 at risk

Adverse event: SVD - Other structural valve deterioration
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 258 at risk

Adverse event: Sepsis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Sternal / Thoracic Wound Complication
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 258 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 258 at risk

Adverse event: Thromboembolism - Non-cerebral
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Thromboembolism - TIA
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 258 at risk

Adverse event: Tricuspid Regurgitation (Native)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 258 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 258 at risk

Adverse event: Vascular Complication
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 258 at risk

Adverse event: Vision Disorder
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 258 at risk