Study: NCT00760617

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Locked-in syndrome
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 266 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 3 affected / 266 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 3 affected / 266 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 2 affected / 266 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 2 affected / 266 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Cartilage injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 266 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 108 affected / 265 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 43 affected / 265 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 265 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 265 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 51 affected / 265 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 24 affected / 265 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 39 affected / 265 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 265 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 37 affected / 265 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 266 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 144 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 144 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 144 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE assessed from Day 180.
Frequency: 1 affected / 144 at risk

Adverse event: Embolic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from Day 180.
Frequency: 1 affected / 144 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE assessed from Day 180.
Frequency: 1 affected / 144 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: SAE assessed from Day 180.
Frequency: 1 affected / 144 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 18 affected / 144 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 144 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 144 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 144 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 144 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 144 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 144 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 144 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 144 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE assessed from Day 0 to Day 20.
Frequency: 1 affected / 116 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 116 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: SAE assessed between Day 21 and Day 179.
Frequency: 1 affected / 116 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 115 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 115 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 115 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 115 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 115 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 9 affected / 115 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 30 affected / 115 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 115 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 115 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 116 at risk