Study: NCT00807040

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 126 at risk

Adverse event: Arrhythmias - Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 126 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 126 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 126 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 126 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 126 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 126 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 126 at risk

Adverse event: Neurological Dysfunction - CVA-Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Neurological Dysfunction - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 126 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 126 at risk

Adverse event: Renal failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 126 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 126 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 126 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 126 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 126 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 126 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Arrhythmia - Undifferentiated
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 126 at risk

Adverse event: Broken bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 126 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Cardiac conduction abnormalities requiring permanent pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Carotid Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 126 at risk

Adverse event: Coagulopathy/HIT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 126 at risk

Adverse event: Collapsed lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 126 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: GI Bleed/GI Issue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 126 at risk

Adverse event: Hemi-diaphragm paralysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypoxic Ischemic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Left Atrial Thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 126 at risk

Adverse event: PM or ICD Implant/Revision
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 126 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 126 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Right Hip Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 126 at risk

Adverse event: Urinary retention/obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Vasoplegia
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 126 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 126 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 126 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 126 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 126 at risk

Adverse event: Myocardial infarction - Peri-Percutaneous Intervention MI
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 126 at risk

Adverse event: Renal failure (dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 126 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 126 at risk

Adverse event: Venous Thromboembolism Event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: GI Bleed/GI Issue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 126 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: Left groin lymphocele/seroma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Urinary retention/obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 126 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 125 at risk

Adverse event: Arrhythmias - Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 125 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 125 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 125 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 125 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Myocardial infarction - Peri-CABG MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 125 at risk

Adverse event: Neurological Dysfunction - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 125 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Neurological Dysfunction - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 125 at risk

Adverse event: Renal failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 125 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 125 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 125 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 125 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Aortic Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arrhythmia - Undifferentiated
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 125 at risk

Adverse event: Broken bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 125 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cardiac conduction abnormalities requiring permanent pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Coagulopathy/HIT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: GI Bleed/GI Issue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 125 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Inguinal Hernia Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 125 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 125 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: PM or ICD Implant/Revision
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 125 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Penetrating Thoracic Ulcer
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Re-Operation for Severe Mitral Valve Leakage
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Right groin pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Vasoplegia
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 125 at risk

Adverse event: non-cardiac musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 125 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 125 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 125 at risk

Adverse event: Neurological Dysfunction - Other*
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 125 at risk

Adverse event: Renal failure (dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 125 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 125 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 125 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arrhythmia - Undifferentiated
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 125 at risk

Adverse event: Broken bone
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Coagulopathy/HIT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 125 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 125 at risk

Adverse event: Electrolyte imbalance
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk