Study: NCT00246753

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 29 at risk

Adverse event: ALT, SGPT (serum glutamic pyruvic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 29 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: AST, SGOT(serum glutamic oxaloacetic transaminase)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bladder spasms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 29 at risk

Adverse event: Elevated Phosphorus
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Cholesterol, serum-high (hypercholesteremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Skin lesions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 29 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dry mouth/salivary gland (xerostomia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Edema: limb
Serious: no
Organ System: General disorders
Frequency: 5 affected / 29 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 29 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 29 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 4 affected / 29 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Glucose, serum-high (hyperglycemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 29 at risk

Adverse event: Hemorrhage, GU - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Gross hematuria
Serious: no
Organ System: Vascular disorders
Notes: 1 x daily
Frequency: 1 affected / 29 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 29 at risk

Adverse event: Incontinence, urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 29 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 29 at risk

Adverse event: Joint-function
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Leak (including anastomotic), GU - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: Magnesium, serum-high (hypermagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 29 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Anus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Mucositis/stomatitis (clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Right-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Nasal cavity/paranasal sinus reactions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 29 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Obstruction, GU - Bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Cardiac/heart
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain - Chest wall
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 29 at risk

Adverse event: Pain - Joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 29 at risk

Adverse event: Pain - Muscle
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pain - Pain NOS
Serious: no
Organ System: General disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pain-Stomach
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 29 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 29 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 29 at risk

Adverse event: Rash: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 29 at risk

Adverse event: Lower urinary tract symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 29 at risk

Adverse event: Skin breakdown/decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Thyroid function, low (hypothyroidism)
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 29 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 29 at risk

Adverse event: Urticaria (hives, welts, wheals)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Seborrhoea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Bleeding mole
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Heel pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Large stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk