Study: NCT00903370

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 127 at risk

Adverse event: Arrhythmias-Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 127 at risk

Adverse event: Arrhythmias-Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 127 at risk

Adverse event: Cardiac conduction abnormalities requiring PPM
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 127 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 127 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 127 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 127 at risk

Adverse event: Major Infection - Localized - Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 127 at risk

Adverse event: Major Infection - Localized - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 127 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 127 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 127 at risk

Adverse event: Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Renal Dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 127 at risk

Adverse event: Renal Failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 127 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 127 at risk

Adverse event: Arrhythmias-Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 127 at risk

Adverse event: Cardiac conduction abnormalities requiring PPM
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 127 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 127 at risk

Adverse event: Major Infection - Localized - Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 127 at risk

Adverse event: Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Renal Dysfunction (no dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Venous Thromboembolism Event
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 127 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 133 at risk

Adverse event: Arrhythmias-Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Arrhythmias-Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 133 at risk

Adverse event: Cardiac conduction abnormalities requiring PPM
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 133 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 133 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 133 at risk

Adverse event: Non-infectious Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 133 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Major Infection - Localized - Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 133 at risk

Adverse event: Major Infection - Localized - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 133 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 133 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 133 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 133 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 133 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 133 at risk

Adverse event: Neurological Dysfunction - CVA-Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 133 at risk

Adverse event: Renal Dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 133 at risk

Adverse event: Renal Failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 133 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 133 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 133 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 133 at risk

Adverse event: Arrhythmias-Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 133 at risk

Adverse event: Cardiac conduction abnormalities requiring PPM
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 133 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 133 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 133 at risk

Adverse event: Major Infection - Localized - Other
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 133 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: Neurological Dysfunction - Other (not stroke, TIA, Toxic Metabolic Encephalopathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 133 at risk

Adverse event: Renal Dysfunction (no dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 133 at risk

Adverse event: Venous Thromboembolism Event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 133 at risk