Study: NCT00526656

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Death not associated with CTCAE term - Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hemorrhage, GU - Urethra
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk

Adverse event: Infection with no more than Grade 2 ANC: Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Extremity-limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Otitis, middle ear
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 9 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 9 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 9 at risk

Adverse event: PTT (Partial Thromboplastin Time)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Thrombotic microangiopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 9 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dermatology/Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 9 at risk

Adverse event: Wound complication, non-infectious
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Gastritis (including bile reflux gastritis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Salivary gland changes/saliva
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 9 at risk

Adverse event: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hemorrhage, GU - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Colitis, infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Febrile neutropenia (fever of unknown origin >=38.5; no infection, ANC<1.0x10e9/L)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Calcium, serum-high (hypercalcemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Calcium, serum-low (hypocalcemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 9 at risk

Adverse event: Phosphate, serum-low (hypophosphatemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 9 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 9 at risk

Adverse event: Mood alteration - Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Scalp
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Pain - Urethra
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Irregular menses (change from baseline)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: change from baseline
Frequency: 1 affected / 9 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 9 at risk