Study: NCT01135498

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 90 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 90 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Enterocutaneous fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 90 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Folliculitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Blood potassium decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tumour perforation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Dysaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Acne
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Skin toxicity
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Palmar-plantar erythrodysaesthesia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 90 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 90 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 90 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 90 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 90 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neutrophilia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 90 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 90 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 90 at risk

Adverse event: Xerophthalmia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ocular icterus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 90 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 90 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 90 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 90 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 90 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 90 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Rectal tenesmus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Subileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Anal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Lip ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Enteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Gastrointestinal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colitis ischaemic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Aerophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Atrophic glossitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Enterocutaneous fistula
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Anorectal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Large intestine perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 90 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 90 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 18 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 90 at risk

Adverse event: General physical health deterioration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Mucosal dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hernia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Temperature intolerance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 90 at risk

Adverse event: Jaundice cholestatic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Jaundice
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Oral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Escherichia urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Perirectal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Subcutaneous abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Seroma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 90 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 90 at risk

Adverse event: Gamma-glutamyltransferase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 90 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Blood lactate dehydrogenase
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Blood glucose abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 90 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 90 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 90 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Muscle contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cancer pain
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 90 at risk

Adverse event: Tumour perforation
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 90 at risk

Adverse event: Neurotoxicity
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 90 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 90 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 90 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 90 at risk

Adverse event: Aphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ageusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Parosmia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 90 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 90 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 90 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hydronephrosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ureteric obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 90 at risk

Adverse event: Perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 90 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Laryngospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pharyngeal erythema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 90 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 90 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 90 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 90 at risk

Adverse event: Skin hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Skin toxicity
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Skin fissures
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 90 at risk

Adverse event: Cutaneous vasculitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Toxic skin eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Plantar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Nail dystrophy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Acanthosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Onycholysis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 90 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk