Study: NCT01554982

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 166 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 166 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 166 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 166 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 166 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 166 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Pleuropericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 166 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 166 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 166 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Diverticulitis intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Umbilical hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 166 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 166 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 166 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 166 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 166 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 166 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Arteriovenous graft site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Cellulitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Furuncle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Incision site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Meningitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Peritoneal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 166 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 166 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Postoperative wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Vascular graft complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 166 at risk

Adverse event: Vascular graft thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 166 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 166 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 166 at risk

Adverse event: Aspiration pleural cavity
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 166 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 166 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 166 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 166 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 166 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 166 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 166 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Cerebral thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Paraparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 166 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 166 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 166 at risk

Adverse event: Postmenopausal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 166 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 166 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 166 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 166 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 166 at risk

Adverse event: Catheter placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 166 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 166 at risk

Adverse event: Parathyroidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 166 at risk

Adverse event: Peritoneal dialysis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 166 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 166 at risk

Adverse event: Spinal fusion surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 166 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 166 at risk

Adverse event: Brachiocephalic vein stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 166 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 166 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 166 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 166 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 166 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 166 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Complications of transplant surgery
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 166 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 166 at risk

Adverse event: Arteriovenous fistula site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 166 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 166 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 166 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 166 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 166 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 166 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 166 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 166 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 166 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 166 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 166 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 166 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 166 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 166 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 166 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 166 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 166 at risk

Adverse event: Vascular graft complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 166 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 166 at risk