Study: NCT01940120

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 78 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Hematologic - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Infection/Bacteremia/Septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 78 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Cardiac disorders: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Chest pain/Angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 78 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 78 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 78 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 78 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Residual/Recurrent MR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Syncope/Dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 78 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 78 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Gastrointestinal disorders: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 78 at risk

Adverse event: General disorders: Other
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 78 at risk

Adverse event: Generalized weakness/Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 78 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 78 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 78 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 78 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 78 at risk

Adverse event: Nervous system disorders: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Neurologic - Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Renal Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 78 at risk

Adverse event: Renal and urinary disorders: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 78 at risk

Adverse event: Renal insufficiency/Failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 20 affected / 78 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 78 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 78 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 78 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 78 at risk

Adverse event: Arteriovenous (AV) fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 78 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 78 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Embolization
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 78 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 78 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Vascular injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Vascular disorders: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 78 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 26 affected / 78 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 78 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 78 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 78 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 78 at risk

Adverse event: Cardiac disorders: other
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 78 at risk

Adverse event: Chest pain/Angina
Serious: no
Organ System: Cardiac disorders
Frequency: 22 affected / 78 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 78 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 78 at risk

Adverse event: Other rhythm disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 78 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 78 at risk

Adverse event: Residual/recurrent magnetic resonance (MR)
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 78 at risk

Adverse event: Syncope/Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 78 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 78 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 78 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 78 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Gastrointestinal disorders: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 78 at risk

Adverse event: Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: General disorders: Other
Serious: no
Organ System: General disorders
Frequency: 38 affected / 78 at risk

Adverse event: Generalized weakness/Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 78 at risk

Adverse event: Incisional site pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 78 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Mental disorders
Serious: no
Organ System: General disorders
Frequency: 14 affected / 78 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: no
Organ System: General disorders
Frequency: 26 affected / 78 at risk

Adverse event: Skin/Mucosal/Subcutaneous tissue disorders
Serious: no
Organ System: General disorders
Frequency: 10 affected / 78 at risk

Adverse event: Connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 78 at risk

Adverse event: Nervous system disorders: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 78 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Renal Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 78 at risk

Adverse event: Renal and urinary disorders: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 78 at risk

Adverse event: Renal insufficiency/Failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 78 at risk

Adverse event: Bronchial/Lung disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 78 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 78 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 78 at risk

Adverse event: Bleeding complication
Serious: no
Organ System: Vascular disorders
Frequency: 34 affected / 78 at risk

Adverse event: Blood pressure complication
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 78 at risk

Adverse event: Bruise/Contusion/Ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 78 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 78 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 78 at risk

Adverse event: Vascular disorders: Other
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 78 at risk