Study: NCT00806988

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Arrhythmias - Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 150 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 150 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 150 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 150 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 150 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 150 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 150 at risk

Adverse event: Neurological Dysfunction - CVA-Hemorrhagic
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 150 at risk

Adverse event: Neurological Dysfunction - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 150 at risk

Adverse event: Renal failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 150 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 150 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 150 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 150 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 150 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 150 at risk

Adverse event: 2 Degree AV Block Type 1
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Acute vision loss, non-neurological
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 150 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Annuloplasty ring dehiscence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bradyarrhythmia requiring pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 150 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 150 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Carotid Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 150 at risk

Adverse event: Chest Pain/ACS
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 150 at risk

Adverse event: Coagulopathy/HIT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Coagulopathy/HIT (-)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 150 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 150 at risk

Adverse event: GI Bleed/GI Issue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 150 at risk

Adverse event: Heart transplant
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 150 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 150 at risk

Adverse event: Hypoxia and respiratory insufficiency
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: ICD Implant
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 150 at risk

Adverse event: Ischemic Left hand
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: LV apical cannula clot
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Left superficial femoral artery pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Lower extremity ischemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Malfunctioning PM
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Non Sustained VT
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 150 at risk

Adverse event: Organ transplant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Pill esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: R/O LV Thrombus
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Small bowel obstruction/ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 150 at risk

Adverse event: Torn aorta
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Nephrectomy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Right Axillary hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 150 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 150 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 150 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 150 at risk

Adverse event: Neurological Dysfunction - Toxic Metabolic Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 150 at risk

Adverse event: Neurological Dysfunction - Other*
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 150 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 150 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Hemetemesis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 150 at risk

Adverse event: Neurological Dysfunction - TIA
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 150 at risk

Adverse event: Bradyarrhythmia requiring pacemaker
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 150 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 151 at risk

Adverse event: Arrhythmias - Sustained ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 151 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 151 at risk

Adverse event: Pericardial Fluid Collection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Major Infection - Localized
Serious: yes
Organ System: Infections and infestations
Frequency: 15 affected / 151 at risk

Adverse event: Major Infection - Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Major Infection - Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 151 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Myocardial infarction - Peri-CABG MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Myocardial infarction - Peri-Percutaneous Intervention MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Neurological Dysfunction - TIA
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Neurological Dysfunction - CVA-Ischemic
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 151 at risk

Adverse event: Neurological Dysfunction - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Renal dysfunction (no dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 151 at risk

Adverse event: Renal failure (dialysis)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 151 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 151 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 26 affected / 151 at risk

Adverse event: Arterial Non-CNS Thromboembolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: Venous Thromboembolism Event
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 151 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 151 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 151 at risk

Adverse event: Abdominal Aortic Aneurysm with claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Bradyarrhythmia requiring pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Bradycardia requiring pacemaker
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Broken Bone
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Carotid Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Chest Pain/ACS
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 151 at risk

Adverse event: Chest Pain/ACS/PCI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Coagulopathy/HIT
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Contrast induced nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 151 at risk

Adverse event: Depression and anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: GI Bleed/GI Issue
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 151 at risk

Adverse event: Gangrenous Toe
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 151 at risk

Adverse event: Ischemic Bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Non-healing wound
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 151 at risk

Adverse event: Peripheral vascular disease/BKA
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Post anesthetic Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 151 at risk

Adverse event: Small bowel obstruction/ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sternal Non-Union
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Haemostasis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Arrhythmias - Sustained supraventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 151 at risk

Adverse event: Major Infection - Localized
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 151 at risk

Adverse event: Myocardial infarction - Peri-CABG MI
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Neurological Dysfunction - Other*
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Venous Thromboembolism Event
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 151 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: GI Bleed/GI Issue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pressure ulcers
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Non-healing wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk