Study: NCT01593917

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 329 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 329 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 329 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cardiac Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 93 affected / 329 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 329 at risk

Adverse event: Heart Failure Signs and Symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 329 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 329 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 329 at risk

Adverse event: Prosthetic cardiac valve regurgitation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 329 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Structural Valve Deterioration, Explanted
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 329 at risk

Adverse event: Structural Valve Deterioration, Transcatheter Valve-in-Valve Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 329 at risk

Adverse event: Structural Valve Deterioration without Reintervention
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 329 at risk

Adverse event: Valve Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 329 at risk

Adverse event: Diabetic Hyperglycemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 329 at risk

Adverse event: Thyroid Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 329 at risk

Adverse event: Eye Disorders
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 329 at risk

Adverse event: Abdominal Hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 329 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Esophageal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 329 at risk

Adverse event: Vomiting, Diarrhea, Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 329 at risk

Adverse event: Intestinal Disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 329 at risk

Adverse event: Death from Unknown Causes
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 329 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 329 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 329 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 329 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 329 at risk

Adverse event: Heat stroke
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 329 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 329 at risk

Adverse event: Event Classification Unknown
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 329 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 329 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 329 at risk

Adverse event: Bacteremia or Septicemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 329 at risk

Adverse event: Lower Respiratory Tract And Lung Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 329 at risk

Adverse event: Wound Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 329 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 329 at risk

Adverse event: Joint Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 329 at risk

Adverse event: Benign Lesions
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 329 at risk

Adverse event: Malignancies
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 28 affected / 329 at risk

Adverse event: Delerium
Serious: yes
Organ System: Nervous system disorders
Frequency: 17 affected / 329 at risk

Adverse event: Siezure Disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 329 at risk

Adverse event: Concussion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 329 at risk

Adverse event: Psychiatric Disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 329 at risk

Adverse event: Renal Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 329 at risk

Adverse event: Urinary Tract Disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 24 affected / 329 at risk

Adverse event: Reproductive System and Breast Disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 329 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 329 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 329 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 329 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 329 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 329 at risk

Adverse event: Lacerations or Contusions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 329 at risk

Adverse event: Rashes, Eruptions And Exanthems
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 329 at risk

Adverse event: Aortic Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 329 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 329 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 329 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 329 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 329 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 19 affected / 329 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Air embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 329 at risk

Adverse event: Minor Bleeding
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 329 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Klebsiella Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 329 at risk

Adverse event: Fractures
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 329 at risk

Adverse event: Tendon, Ligament and Cartilage Disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 329 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Guillain-Barré Syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 329 at risk

Adverse event: Respiratory Tract Signs and Symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 329 at risk

Adverse event: Chronic respiratory disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk

Adverse event: Barotrauma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 329 at risk