Study: NCT00021255

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 1018 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1018 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 1018 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1018 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1018 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 1018 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1018 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1018 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1018 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1018 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 85 affected / 1018 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 68 affected / 1018 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Ear pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1018 at risk

Adverse event: Endometrial disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1018 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Application site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1018 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1018 at risk

Adverse event: Nail disorder
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1018 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 81 affected / 1018 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 40 affected / 1018 at risk

Adverse event: Left ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 1018 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 69 affected / 1018 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 50 affected / 1018 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 230 affected / 1018 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 383 affected / 1018 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 439 affected / 1018 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 204 affected / 1018 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 890 affected / 1018 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 660 affected / 1018 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 563 affected / 1018 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 179 affected / 1018 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 100 affected / 1018 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 838 affected / 1018 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 82 affected / 1018 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 73 affected / 1018 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 58 affected / 1018 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 162 affected / 1018 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 301 affected / 1018 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 350 affected / 1018 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 66 affected / 1018 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 222 affected / 1018 at risk

Adverse event: Amblyopia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 1018 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: General disorders
Frequency: 111 affected / 1018 at risk

Adverse event: Dry eye
Serious: no
Organ System: General disorders
Frequency: 41 affected / 1018 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: General disorders
Frequency: 210 affected / 1018 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 291 affected / 1018 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 77 affected / 1018 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 339 affected / 1018 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 197 affected / 1018 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 81 affected / 1018 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 439 affected / 1018 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 187 affected / 1018 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 541 affected / 1018 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 86 affected / 1018 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 106 affected / 1018 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 112 affected / 1018 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 87 affected / 1018 at risk

Adverse event: Affect lability
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 1018 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 226 affected / 1018 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 514 affected / 1018 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Nervous system disorders
Frequency: 364 affected / 1018 at risk

Adverse event: Breast pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 53 affected / 1018 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 1018 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 368 affected / 1018 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 187 affected / 1018 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 227 affected / 1018 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 1018 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 1018 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 175 affected / 1018 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1003 affected / 1018 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 76 affected / 1018 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 1018 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 275 affected / 1018 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 507 affected / 1018 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 1018 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 238 affected / 1018 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 1018 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 1018 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1100 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 1100 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 1100 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 25 affected / 1100 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1100 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1100 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 1100 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1100 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1100 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 1100 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1100 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1100 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1100 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 109 affected / 1100 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Immune system disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 85 affected / 1100 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Radiation injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Deafness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Otitis media
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Vestibular disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1100 at risk

Adverse event: Enzyme abnormality
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1100 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Bronchiectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1100 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1100 at risk

Adverse event: Rhinitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1100 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Acne
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Application site reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Benign neoplasm of skin
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1100 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 94 affected / 1100 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 72 affected / 1100 at risk

Adverse event: Left ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 71 affected / 1100 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 94 affected / 1100 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 62 affected / 1100 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 238 affected / 1100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 403 affected / 1100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 555 affected / 1100 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 273 affected / 1100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 967 affected / 1100 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 735 affected / 1100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 628 affected / 1100 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 220 affected / 1100 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 137 affected / 1100 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 925 affected / 1100 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 132 affected / 1100 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 103 affected / 1100 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 88 affected / 1100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 206 affected / 1100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 323 affected / 1100 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 445 affected / 1100 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 70 affected / 1100 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 268 affected / 1100 at risk

Adverse event: Amblyopia
Serious: no
Organ System: General disorders
Frequency: 52 affected / 1100 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: General disorders
Frequency: 122 affected / 1100 at risk

Adverse event: Dry eye
Serious: no
Organ System: General disorders
Frequency: 56 affected / 1100 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: General disorders
Frequency: 264 affected / 1100 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 312 affected / 1100 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 1100 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 405 affected / 1100 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 262 affected / 1100 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 100 affected / 1100 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 515 affected / 1100 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 235 affected / 1100 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 614 affected / 1100 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 78 affected / 1100 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 139 affected / 1100 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 154 affected / 1100 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 1100 at risk

Adverse event: Affect lability
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 1100 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 288 affected / 1100 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 569 affected / 1100 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Nervous system disorders
Frequency: 416 affected / 1100 at risk

Adverse event: Breast pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 59 affected / 1100 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 51 affected / 1100 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 356 affected / 1100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 205 affected / 1100 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 270 affected / 1100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 143 affected / 1100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 1100 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 277 affected / 1100 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1083 affected / 1100 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 101 affected / 1100 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 1100 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 354 affected / 1100 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 484 affected / 1100 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 1100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 279 affected / 1100 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 1100 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 1100 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1056 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 1056 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Congenital arterial malformation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 1056 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1056 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1056 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1056 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1056 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Adverse reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1056 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1056 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1056 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1056 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1056 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 86 affected / 1056 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 85 affected / 1056 at risk

Adverse event: Injection site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Mucosal disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Unevaluable event
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 1056 at risk

Adverse event: Oedema
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1056 at risk

Adverse event: Trismus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Breast neoplasm
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Menstrual disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Urinary tract disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1056 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Fungal skin infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1056 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1056 at risk

Adverse event: Lymphoedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 107 affected / 1056 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 78 affected / 1056 at risk

Adverse event: Left ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 31 affected / 1056 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 95 affected / 1056 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 67 affected / 1056 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 252 affected / 1056 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 351 affected / 1056 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 658 affected / 1056 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 263 affected / 1056 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 863 affected / 1056 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 564 affected / 1056 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 428 affected / 1056 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 240 affected / 1056 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 153 affected / 1056 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 878 affected / 1056 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 96 affected / 1056 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 1056 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 78 affected / 1056 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 145 affected / 1056 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 306 affected / 1056 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 327 affected / 1056 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 84 affected / 1056 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 217 affected / 1056 at risk

Adverse event: Amblyopia
Serious: no
Organ System: General disorders
Frequency: 55 affected / 1056 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: General disorders
Frequency: 45 affected / 1056 at risk

Adverse event: Dry eye
Serious: no
Organ System: General disorders
Frequency: 30 affected / 1056 at risk

Adverse event: Lacrimation disorder
Serious: no
Organ System: General disorders
Frequency: 124 affected / 1056 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 320 affected / 1056 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 1056 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 347 affected / 1056 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 254 affected / 1056 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 69 affected / 1056 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 335 affected / 1056 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 144 affected / 1056 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 415 affected / 1056 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 70 affected / 1056 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 119 affected / 1056 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 130 affected / 1056 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 1056 at risk

Adverse event: Affect lability
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 1056 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 252 affected / 1056 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 406 affected / 1056 at risk

Adverse event: Vasodilatation
Serious: no
Organ System: Nervous system disorders
Frequency: 384 affected / 1056 at risk

Adverse event: Breast pain
Serious: no
Organ System: Renal and urinary disorders
Frequency: 62 affected / 1056 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 58 affected / 1056 at risk

Adverse event: Menstrual disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 384 affected / 1056 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 147 affected / 1056 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 229 affected / 1056 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 170 affected / 1056 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 60 affected / 1056 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 193 affected / 1056 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1018 affected / 1056 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 1056 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 1056 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 330 affected / 1056 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 303 affected / 1056 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 1056 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 313 affected / 1056 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 1056 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 1056 at risk