Study: NCT01288976

Adverse event: Atrial Septal Defect (ASD)
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 567 at risk

Adverse event: Arteriovenous (AV) fistula Fistula
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 567 at risk

Adverse event: Atrioventricular block (AV block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 567 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 567 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 567 at risk

Adverse event: Aortic Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 567 at risk

Adverse event: Arrhythmia, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 567 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 567 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 567 at risk

Adverse event: Atrial arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 45 affected / 567 at risk

Adverse event: Bacteremia/Septicemea
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 567 at risk

Adverse event: Bleeding complications
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 567 at risk

Adverse event: Blood pressure complications
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 567 at risk

Adverse event: Bone and Joint Injuries
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 567 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 76 affected / 567 at risk

Adverse event: Bronchial and Lung disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 567 at risk

Adverse event: Bruise/Contusion/Ecchymosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 567 at risk

Adverse event: Coronary artery disease (CAD)
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 567 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 567 at risk

Adverse event: Cardiac: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 31 affected / 567 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 567 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 567 at risk

Adverse event: Cerebro-vascular : Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 567 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 567 at risk

Adverse event: Coagulopathology
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 567 at risk

Adverse event: Cough (non-productive)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 567 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 567 at risk

Adverse event: Device complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 567 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 45 affected / 567 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 567 at risk

Adverse event: Epidermal and dermal conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 567 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 567 at risk

Adverse event: Oesophageal injury
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 567 at risk

Adverse event: Eye disorders
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 567 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 567 at risk

Adverse event: Gastrointestinal (GI) hemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 567 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 567 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 567 at risk

Adverse event: Gastrointestinal motility
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 567 at risk

Adverse event: Generalized pain
Serious: yes
Organ System: General disorders
Frequency: 12 affected / 567 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 18 affected / 567 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 98 affected / 567 at risk

Adverse event: Hematologic Miscellaneous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 567 at risk

Adverse event: Hematoma: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 24 affected / 567 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 567 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 567 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 567 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 567 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 567 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 567 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 567 at risk

Adverse event: Mental disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 17 affected / 567 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 567 at risk

Adverse event: Miscellaneous
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 567 at risk

Adverse event: Mitral Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 34 affected / 567 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 567 at risk

Adverse event: Musculoskeletal other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 567 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 567 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 567 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 567 at risk

Adverse event: Miscellaneous:other
Serious: yes
Organ System: General disorders
Frequency: 55 affected / 567 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 567 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 567 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 567 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 567 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 567 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 47 affected / 567 at risk

Adverse event: Renal: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 567 at risk

Adverse event: Renal/Urinary Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 27 affected / 567 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 567 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Skin infections
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 567 at risk

Adverse event: Stroke (ischemic or hemorrhagic)
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 567 at risk

Adverse event: Syncope and dizziness
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 567 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 567 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 567 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 567 at risk

Adverse event: Tricuspid Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 567 at risk

Adverse event: Urinary Miscellaneous
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 567 at risk

Adverse event: Vascular : other
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 567 at risk

Adverse event: Ventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 24 affected / 567 at risk

Adverse event: Atrial Septal Defect (ASD)
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 567 at risk

Adverse event: Arteriovenous (AV) fistula Fistula
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 567 at risk

Adverse event: Atrioventricular block (AV block)
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 567 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 567 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 567 at risk

Adverse event: Aortic Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 567 at risk

Adverse event: Arrhythmia, Other
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 567 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 567 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 567 at risk

Adverse event: Atrial arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 45 affected / 567 at risk

Adverse event: Bacteremia/Septicemea
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 567 at risk

Adverse event: Bleeding complications
Serious: no
Organ System: Vascular disorders
Frequency: 26 affected / 567 at risk

Adverse event: Blood pressure complications
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 567 at risk

Adverse event: Bone and Joint Injuries
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 567 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 76 affected / 567 at risk

Adverse event: Bronchial and Lung disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 567 at risk

Adverse event: Bruise/Contusion/Ecchymosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 567 at risk

Adverse event: Coronary artery disease (CAD)
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 567 at risk

Adverse event: Chronic Obstructive Pulmonary Disease (COPD)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 567 at risk

Adverse event: Cardiac: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 567 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 567 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 567 at risk

Adverse event: Cerebrovascular : Other
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 567 at risk

Adverse event: Circulatory collapse
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 567 at risk

Adverse event: Coagulopathology
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 567 at risk

Adverse event: Cough (non-productive)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 567 at risk

Adverse event: Device complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 567 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 567 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 567 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 567 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 3 affected / 567 at risk

Adverse event: Oesophageal injury
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 567 at risk

Adverse event: Eye disorders
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 567 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 567 at risk

Adverse event: Gastrointestinal (GI) hemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 567 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 567 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 567 at risk

Adverse event: Gastrointestinal motility
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 567 at risk

Adverse event: Generalized pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 567 at risk

Adverse event: Generalized weakness/fatigue
Serious: no
Organ System: General disorders
Frequency: 18 affected / 567 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 98 affected / 567 at risk

Adverse event: Hematologic Miscellaneous
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 567 at risk

Adverse event: Hematoma: Other
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 567 at risk

Adverse event: Haemolysis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 567 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 567 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 567 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 567 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 567 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 567 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 567 at risk

Adverse event: Mental disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 567 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 567 at risk

Adverse event: Miscellaneous
Serious: no
Organ System: General disorders
Frequency: 8 affected / 567 at risk

Adverse event: Mitral Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 567 at risk

Adverse event: Musculoskeletal and connective tissue disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 567 at risk

Adverse event: Musculoskeletal other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 567 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 567 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 567 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 567 at risk

Adverse event: Miscellaneous : other
Serious: no
Organ System: General disorders
Frequency: 55 affected / 567 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 567 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 567 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 567 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 567 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 567 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 567 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 47 affected / 567 at risk

Adverse event: Renal: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 567 at risk

Adverse event: Renal/Urinary Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 567 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 567 at risk

Adverse event: Retroperitoneal haematoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 567 at risk

Adverse event: Skin infections
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 567 at risk

Adverse event: Stroke (ischemic or hemorrhagic)
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 567 at risk

Adverse event: Syncope and dizziness
Serious: no
Organ System: General disorders
Frequency: 21 affected / 567 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 567 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 567 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 567 at risk

Adverse event: Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 567 at risk

Adverse event: Urinary Miscellaneous
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 567 at risk

Adverse event: Vascular : other†
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 567 at risk

Adverse event: Ventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 567 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arrhythmia, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: Atrial arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hematologic Miscellaneous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Mitral Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Miscellaneous:other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Syncope and dizziness
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Tricuspid Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Ventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Arrhythmia, Other
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 49 at risk

Adverse event: Atrial arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 49 at risk

Adverse event: Breathing abnormalities
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiac: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Generalized weakness/fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hematologic Miscellaneous
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 49 at risk

Adverse event: Mitral Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Miscellaneous : other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 49 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 49 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Syncope and dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 49 at risk

Adverse event: Tricuspid Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Ventricular arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 49 at risk

Adverse event: Atrioventricular block (AV block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 105 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Arrhythmia, Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 105 at risk

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 105 at risk

Adverse event: Atrial arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 20 affected / 105 at risk

Adverse event: Bacteremia/Septicemea
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: Bleeding complications
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Cardiac: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 105 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 105 at risk

Adverse event: Generalized weakness/fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hematologic Miscellaneous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hematoma: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 105 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 105 at risk

Adverse event: Mental disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 105 at risk

Adverse event: Mitral Valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Miscellaneous:other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 105 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 105 at risk

Adverse event: Renal/Urinary Infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Syncope and dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Vascular : other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Lower respiratory disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Atrioventricular block (AV block)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 105 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Arrhythmia, Other
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 105 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 105 at risk

Adverse event: Atrial arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 20 affected / 105 at risk

Adverse event: Bacteremia/Septicemea
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 105 at risk

Adverse event: Bleeding complications
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Cardiac: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Circulatory collapse
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 105 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Gastrointestinal (GI) Infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gastrointestinal (GI) : Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 105 at risk

Adverse event: Generalized weakness/fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Hematologic Miscellaneous
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hematoma: Other
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 105 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 105 at risk

Adverse event: Mental disorders
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 105 at risk

Adverse event: Metabolic/Endocrine disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 105 at risk

Adverse event: Mitral Valve
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 105 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 105 at risk

Adverse event: Miscellaneous : other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 105 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 105 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 105 at risk

Adverse event: Renal/Urinary Infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 105 at risk

Adverse event: Syncope and dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 105 at risk

Adverse event: Transient ischemic attack (TIA)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 105 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Vascular : other†
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 105 at risk

Adverse event: Lower respiratory disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk