Study: NCT00245128

Adverse event: Pleural Effusions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Hypersensitivity pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 10 at risk

Adverse event: Elevated CPK
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Acute leukaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 10 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Optic nerve atrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: hospitalization for bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oncocytoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Extra pyramidal symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Meningitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Bilirubin and lipase
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: ateriovenus malformation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oesophageal fistula
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatal diverticulitis, gastrointestinal peforation, peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Fatal pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Eyelid ptosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Disease progression
Frequency: 1 affected / 10 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Priapism
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Squamous cell carcinoma of the penis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Leydig cell hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Plaques of demyelination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Interstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Metastases of breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 10 at risk