Study: NCT00576303

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 200 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pancreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 200 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Ill-defined disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 200 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Hepatitis B
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pyelonephritis chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pyonephrosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Renal cyst infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Arteriovenous fistula aneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 200 at risk

Adverse event: Peritoneal dialysis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Traumatic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Glucose tolerance impaired
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Colon neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 200 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 200 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 200 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Conduction disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 200 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 200 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 200 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Retinopathy hypertensive
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 200 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Erosive oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 200 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastritis erosive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 200 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 200 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastrooesophageal sphincter insufficiency
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 200 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 200 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 200 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hyperthermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Hepatitis B
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pyelonephritis acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pyelonephritis chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Pyonephrosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Viral hepatitis carrier
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Anaemia postoperative
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Arteriovenous fistula site haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 200 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Humerus fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Poisoning
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Post procedural fistula
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 200 at risk

Adverse event: Scapula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 200 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 200 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 200 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 200 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 200 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 200 at risk

Adverse event: Osteochondrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Periostitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Synovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Gastric cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 200 at risk

Adverse event: Hypotonia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Intracranial aneurysm
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Polyneuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Lumbosacral radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 200 at risk

Adverse event: Calculus urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 200 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 200 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 200 at risk

Adverse event: Bronchitis chronic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pleurisy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 200 at risk

Adverse event: Purpura
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Aortic arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 200 at risk

Adverse event: Ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Post thrombotic syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk