Study: NCT00209274

Adverse event: Mitral Valve (MV) surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: cardiac-single leaflet device attachment (SLDA)
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 178 at risk

Adverse event: Tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 178 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 178 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 178 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Chest pain/angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 178 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 178 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Lead displacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 178 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Mitral valve injury
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Cardiac:Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 178 at risk

Adverse event: Cardiac:Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 178 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 178 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Residual/recurrent mitral regurgitation (MR)
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 178 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 178 at risk

Adverse event: Syncope/dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 178 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 178 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 178 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 178 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 178 at risk

Adverse event: Gastro intestinal related:Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 178 at risk

Adverse event: Gastro intestinal related:Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Gastro intestinal related:Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 178 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 178 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 178 at risk

Adverse event: Infection/bacteremia/septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 178 at risk

Adverse event: Hematologic:Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 178 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 178 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 178 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 178 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 178 at risk

Adverse event: Neurologic:Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 178 at risk

Adverse event: Neurologic:Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 178 at risk

Adverse event: Generalized weakness/fatigue:other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 178 at risk

Adverse event: Infection:Other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 178 at risk

Adverse event: Mental disorders:Other
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 178 at risk

Adverse event: Metabolic/endocrine disorders:Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 178 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 178 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders:other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Renal-Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 178 at risk

Adverse event: Renal-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 178 at risk

Adverse event: Renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 178 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Respiratory:Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 178 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 178 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 178 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 178 at risk

Adverse event: Arteriovenous (AV) fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Deep vein thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 178 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 178 at risk

Adverse event: Blood pressure complication
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 178 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 178 at risk

Adverse event: Vascular:Injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Vascular:Other
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 178 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 178 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 178 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 178 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 178 at risk

Adverse event: Chest pain/angina
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 178 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 178 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 178 at risk

Adverse event: Cardiac:Other rhythm disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 178 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 178 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 178 at risk

Adverse event: Residual/recurrent mitral regurgitation (MR)
Serious: no
Organ System: Cardiac disorders
Frequency: 29 affected / 178 at risk

Adverse event: Syncope/dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 38 affected / 178 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 178 at risk

Adverse event: Gastrointestinal:Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 178 at risk

Adverse event: Gastrointestinal-Bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 178 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 178 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 178 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 178 at risk

Adverse event: Connective tissue disorders:other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 76 affected / 178 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 178 at risk

Adverse event: Neurologic:Other
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 178 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 178 at risk

Adverse event: Generalized weakness/fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 178 at risk

Adverse event: Incisional site pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 178 at risk

Adverse event: Mental disorders:other
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 178 at risk

Adverse event: Metabolic/endocrine disorders:other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 178 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 78 affected / 178 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders:other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 178 at risk

Adverse event: Renal:Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 178 at risk

Adverse event: Renal-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 178 at risk

Adverse event: Renal insufficiency/failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 178 at risk

Adverse event: Bronchial/lung disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 178 at risk

Adverse event: Respiratory:Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 178 at risk

Adverse event: Respiratory:Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 79 affected / 178 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 178 at risk

Adverse event: Bleeding complication
Serious: no
Organ System: Vascular disorders
Frequency: 62 affected / 178 at risk

Adverse event: Blood pressure complication
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 178 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 178 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 178 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 178 at risk

Adverse event: Vascular:Other
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 178 at risk

Adverse event: Arrhythmia supraventricular
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 80 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 80 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Chest pain/angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 80 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 80 at risk

Adverse event: Cardiac:Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 80 at risk

Adverse event: Cardiac:Other rhythm disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 80 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 80 at risk

Adverse event: Residual/recurrent mitral regurgitation (MR)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 80 at risk

Adverse event: Syncope/dizziness
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 80 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 80 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Gastro intestinal related:Bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Gastro intestinal related:Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Gastro intestinal related:Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 80 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Infection/bacteremia/septicemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Hematologic:Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Neurologic:Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Neurologic:Stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 80 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Generalized weakness/fatigue:other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Infection:Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Metabolic/endocrine disorders:Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 80 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 80 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Incisional site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Renal-Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Renal-Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 80 at risk

Adverse event: Renal insufficiency/failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 80 at risk

Adverse event: Chronic obstructive pulmonary disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Bronchial/lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 80 at risk

Adverse event: Respiratory:Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Bleeding complication
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 80 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Haemodynamic instability
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 80 at risk

Adverse event: Vascular:Injury
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Vascular:Other
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 80 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 80 at risk

Adverse event: Vascular:Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 80 at risk

Adverse event: Bradyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 80 at risk

Adverse event: Chest pain/angina
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 80 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 80 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 80 at risk

Adverse event: Cardiac:Other rhythm disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 80 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 80 at risk

Adverse event: Residual/recurrent mitral regurgitation (MR)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Syncope/dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 80 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 80 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 80 at risk

Adverse event: Cardiac:Other
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 80 at risk

Adverse event: Gastrointestinal:Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 80 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 80 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 80 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 80 at risk

Adverse event: Hematologic:Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 80 at risk

Adverse event: Connective tissue disorders:other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 80 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 80 at risk

Adverse event: Neurologic:Other
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 80 at risk

Adverse event: Generalized weakness/fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 80 at risk

Adverse event: Incisional site pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 80 at risk

Adverse event: Mental disorders:other
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 80 at risk

Adverse event: Metabolic/endocrine disorders:other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 80 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 35 affected / 80 at risk

Adverse event: Skin/mucosal/subcutaneous tissue disorders:other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Renal:Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 80 at risk

Adverse event: Renal-Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 80 at risk

Adverse event: Renal insufficiency/failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 80 at risk

Adverse event: Bronchial/lung disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 80 at risk

Adverse event: Respiratory:Infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Respiratory:Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 80 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 80 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 80 at risk

Adverse event: Bleeding complication
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 80 at risk

Adverse event: Blood pressure complication
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 80 at risk

Adverse event: Bruise/contusion/ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 80 at risk

Adverse event: Haemodynamic instability
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 80 at risk

Adverse event: Transfusion
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 80 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Mitral valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 80 at risk