Study: NCT00157573

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 35 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 35 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 35 at risk

Adverse event: Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 35 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Induration/fibrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 35 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 35 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 35 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 35 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhea without prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 35 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 35 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 3 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 35 at risk

Adverse event: Abdomen pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 35 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 35 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 35 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

Adverse event: Extremity limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 35 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pulmonary/upper respiratory other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Distention/bloating abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Neuropathy sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pain other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 37 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 37 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 37 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 37 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 37 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 37 at risk

Adverse event: Rigors/Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 37 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 37 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Diarrhea without prior colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 37 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 37 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 37 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 37 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 37 at risk

Adverse event: Abdomen pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 37 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 37 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 36 affected / 37 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 37 at risk

Adverse event: Extremity limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 37 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 37 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 37 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Pulmonary/upper respiratory other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 37 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Hematologic-other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 37 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 37 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 37 at risk

Adverse event: Distention/bloating abdominal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 37 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Gastrointestinal other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 37 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk

Adverse event: Edema limb
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 37 at risk

Adverse event: Neuropathy sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 37 at risk

Adverse event: Ocular other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 37 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 37 at risk

Adverse event: Pain other
Serious: no
Organ System: General disorders
Frequency: 3 affected / 37 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 37 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 37 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 37 at risk