Study: NCT00543127

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 415 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 415 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 415 at risk

Adverse event: Injection site reaction/extravasation changes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 415 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastritis (including bile reflux gastritis)
Frequency: 1 affected / 415 at risk

Adverse event: Ileus, gi (functional obstruction of bowel, i.e., neuroconstipation)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 415 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Rectum cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Ulcer, gi - duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Hemorrhage, CNS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 415 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 415 at risk

Adverse event: acute hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 415 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 415 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 415 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils dermatology/skin skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 415 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - sexual/reproductive function vagina and vulv
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Infection with unknown ANC - gastrointestinal appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Infection with unknown ANC - pulmonary/upper respiratory lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 415 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 415 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Other: tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 415 at risk

Adverse event: Glioblastoma multiforme
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 415 at risk

Adverse event: Musculoskeletal back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Musculoskeletal bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Musculoskeletal joint pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 415 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Secondary malignancy - possiby related to cancer treatment, specify: kidney cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 415 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 415 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 415 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 415 at risk

Adverse event: Gastric difuse
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 415 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 41 affected / 415 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 49 affected / 415 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 39 affected / 415 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 37 affected / 415 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 23 affected / 415 at risk

Adverse event: Cholesterol, serum-high (hypercholesterolemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 415 at risk

Adverse event: LDL-cholesterol high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 415 at risk

Adverse event: Musculoskeletal bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 415 at risk

Adverse event: Musculoskeletal joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 83 affected / 415 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: lymphoblastic leukemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Conduction abnormality/atrioventricular heart block - av block-second degree mobitz type ii
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Supraventricular and nodal arrhythmia - atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Supraventricular and nodal arrhythmia - sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Angor
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 437 at risk

Adverse event: Valvular heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 437 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Induration/fibrosis (skin and subcutaneous tissue)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: T-cell lymphoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 437 at risk

Adverse event: Transverse colon adenocarcinoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Perforation, gi - appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Hemorrhage, gi - colon
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Hemorrhage, gi - stomach
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Hemorrhage/bleeding associated with surgery, intra-operative or postoperative
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 437 at risk

Adverse event: Liver dysfunction/failure (clinical)
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 437 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 437 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 437 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutrophils (anc <1.0 x 109
Serious: yes
Organ System: Infections and infestations
Notes: pulmonary/upper respiratory - lung (pneumonia)
Frequency: 1 affected / 437 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils dermatology/skin skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory upper airway nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with unknown ANC - cardiovascular heart (endocarditis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with unknown ANC - gastrointestinal appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with unknown ANC - gastrointestinal dental-tooth
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with unknown ANC - pulmonary/upper respiratory lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 437 at risk

Adverse event: Infection with unknown ANC - renal/genitourinary urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 437 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: CNS cerebrovascular ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 437 at risk

Adverse event: Neuropathy: craneal - cn vi downward, inward movement of eye
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 437 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 437 at risk

Adverse event: Gastrointestinal abdomen nos pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 437 at risk

Adverse event: Musculoskeletal back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Musculoskeletal bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Musculoskeletal joint pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Musculoskeletal neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 437 at risk

Adverse event: Pulmonary/upper respiratory chest/thorax nos pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 437 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 437 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 437 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 437 at risk

Adverse event: Secondary malignancy - possiby related to cancer treatment, specify: uterine cervix cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 437 at risk

Adverse event: Endometrial adenocarcinoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 437 at risk

Adverse event: Microcalcification in breast
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 437 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 437 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 437 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - renal/genitourinary kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Infection with normal ANC or grade 1 or 2 neutrophils - renal/genitourinary urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 437 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 58 affected / 437 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 437 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 31 affected / 437 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 41 affected / 437 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 437 at risk

Adverse event: Cholesterol, serum-high (hypercholesterolemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 437 at risk

Adverse event: LDL-cholesterol high
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 437 at risk

Adverse event: Musculoskeletal bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 437 at risk

Adverse event: Musculoskeletal joint pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 437 at risk