Study: NCT00667251

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 322 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 322 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 322 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 322 at risk

Adverse event: Sudden death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 322 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 322 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 322 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 322 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 322 at risk

Adverse event: Gastrointestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 322 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 322 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 322 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 322 at risk

Adverse event: Device related infection
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 322 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 322 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 322 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 322 at risk

Adverse event: Ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 322 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 322 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 322 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 322 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 322 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 322 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 322 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 322 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 322 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 322 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 322 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 322 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 322 at risk

Adverse event: Gastrointestinal anastomotic leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 322 at risk

Adverse event: Injection site reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 322 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 322 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 322 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 322 at risk

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 322 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 322 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 322 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 322 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 322 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 322 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 322 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 322 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 322 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Chills
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 322 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Multifocal motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 322 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pollakiuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 322 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 322 at risk

Adverse event: Sexual dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 322 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 322 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 322 at risk

Adverse event: Pain of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 322 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 322 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 322 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 322 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 322 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 322 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 322 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 322 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 322 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 322 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 322 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 322 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 86 affected / 322 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 322 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 322 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 322 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 322 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 322 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 250 affected / 322 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 322 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 322 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 157 affected / 322 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 138 affected / 322 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 322 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 92 affected / 322 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 225 affected / 322 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 322 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 30 affected / 322 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 322 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 322 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 322 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 322 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Frequency: 20 affected / 322 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 322 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 322 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 107 affected / 322 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 322 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 322 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 322 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 322 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 322 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 322 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 16 affected / 322 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 322 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 66 affected / 322 at risk

Adverse event: Multifocal motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 322 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 322 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 168 affected / 322 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 322 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 322 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 322 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 322 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 65 affected / 322 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 24 affected / 322 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 69 affected / 322 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 75 affected / 322 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 322 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 322 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 322 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 212 affected / 322 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 322 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 129 affected / 322 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 47 affected / 322 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 192 affected / 322 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 322 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 322 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 63 affected / 322 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 322 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 322 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 322 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 322 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 325 at risk

Adverse event: Platelet disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 325 at risk

Adverse event: Sudden death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 325 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 325 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 325 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Fistula of small intestine
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 325 at risk

Adverse event: Oesophageal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 325 at risk

Adverse event: Device related infection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 325 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 325 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 325 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 325 at risk

Adverse event: Hepatobiliary disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 325 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 325 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 325 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 325 at risk

Adverse event: Upper aerodigestive tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 325 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 325 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 325 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 325 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 325 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 325 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 325 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 325 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 325 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 325 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 325 at risk

Adverse event: Sexual dysfunction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 325 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 325 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 325 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 325 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 325 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 325 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 325 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 325 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 325 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 325 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 325 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 325 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 325 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Cardiac disorders
Frequency: 113 affected / 325 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 37 affected / 325 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 325 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 325 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 325 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 325 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 130 affected / 325 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 325 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 325 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 139 affected / 325 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 325 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 325 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 325 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 212 affected / 325 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 325 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 45 affected / 325 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 325 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 325 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 325 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 325 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 325 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 325 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 325 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 74 affected / 325 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 99 affected / 325 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 72 affected / 325 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 79 affected / 325 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 325 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 78 affected / 325 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 52 affected / 325 at risk

Adverse event: Tumour pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 22 affected / 325 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 325 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 325 at risk

Adverse event: Multifocal motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 325 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 325 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 165 affected / 325 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 325 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 34 affected / 325 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 325 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 325 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 325 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 29 affected / 325 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 325 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 325 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 325 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 325 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 325 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 238 affected / 325 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 325 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 88 affected / 325 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 325 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 127 affected / 325 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 325 at risk

Adverse event: Skin infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 325 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 325 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 325 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 325 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 37 affected / 325 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 325 at risk

Adverse event: Musculoskeletal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk