Study: NCT00322452

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 607 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 607 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 607 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 607 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 607 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Cerebral artery embolism
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 607 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 607 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 607 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 607 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 607 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 607 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 607 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 607 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 607 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 607 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 607 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 607 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 607 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 607 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Hyperventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 607 at risk

Adverse event: IIIrd nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 607 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Laryngeal granuloma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 607 at risk

Adverse event: Neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 607 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 607 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 607 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Anisocoria
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 607 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 607 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 607 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 607 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 607 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 607 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 607 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 607 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 607 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 607 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 607 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 607 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 607 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 61 affected / 607 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 607 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 607 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 92 affected / 607 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 607 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 52 affected / 607 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 607 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 607 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 607 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 607 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 273 affected / 607 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 607 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 144 affected / 607 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 607 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 607 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 72 affected / 607 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 607 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 607 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 48 affected / 607 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 607 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 607 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 72 affected / 607 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 607 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 607 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 607 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 607 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 607 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 607 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 607 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 607 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 82 affected / 607 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 607 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 607 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 103 affected / 607 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 607 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 308 affected / 607 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 607 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 607 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 607 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 607 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 607 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 607 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 589 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 589 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 589 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 589 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 589 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 589 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 589 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 589 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 589 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 589 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 589 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 589 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 589 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 589 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 589 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 589 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 589 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 589 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 589 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 589 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 589 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 589 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 589 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 589 at risk

Adverse event: Hypophagia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 589 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 589 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 589 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 589 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 589 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 589 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 589 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 589 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 589 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 589 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 589 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 589 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 589 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 589 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 589 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 589 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 589 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 343 affected / 589 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 146 affected / 589 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 232 affected / 589 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 112 affected / 589 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 589 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 589 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 170 affected / 589 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 62 affected / 589 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 589 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 127 affected / 589 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 589 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 589 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 589 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 589 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 217 affected / 589 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 589 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 589 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 23 affected / 589 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 153 affected / 589 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 30 affected / 589 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 107 affected / 589 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 146 affected / 589 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 186 affected / 589 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 589 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 259 affected / 589 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 589 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 218 affected / 589 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 39 affected / 589 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 589 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 589 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 141 affected / 589 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 589 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 69 affected / 589 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 589 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 120 affected / 589 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 589 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 589 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 589 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 589 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 190 affected / 589 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 52 affected / 589 at risk