(N = 1380) (N =690) (%) (%) Infections and respiratory tract infections (including lower and upper infestations respiratory tract infection, pneumonia, sinusitis, 39 33 pharyngitis, nasopharyngitis and pneumonia herpes viral) oral infections (including herpes simplex, oral herpes 7 5 and tooth infections) reproductive infections (including vulvovaginal 3 1 mycotic infection) and the lymphatic anaemia 13 8 system disorders leucopaenia (including neutropaenia and 14 8 agranulocytosis) leucocystosis 1 0 thrombocytopenia 1 0 Metabolism and lipids increased 17 8 nutrition disorders uric acid increased 6 3 blood sodium abnormal 10 3 hypokalaemia 3 2 hypophosphotaemia 2 1 blood potassium increased 3 1 Nervous system headache 14 8 disorders Vascular disorders hypertension 6 3 flushing 2 1 Respiratory, thoracic cough and mediastinal 7 6 disorders Gastrointestinal nausea and vomiting 12 11 disorders abdominal pain 10 6 sicca syndrome 3 2 GI haemorrhage 2 1 Hepato-biliary liver enzymes elevated 12 8 disorders Skin and subcutaneous rash (including exfoliative rash) 14 7 tissue disorders pruritus 5 1 dermatitis (including eczema) 3 1 bruising (including purpura) 2 0 Musculoskeletal, musculoskeletal pain 14 9 connective tissue and muscle spasms (including creatine bone disorders 5 4 phosphokinase increased) Renal and urinary haematuria 9 4 disorders renal impairment 8 4
(N = 1380) (%) (N =690) (%) Infections and infestations respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) 39 33 oral infections (including herpes simplex, oral herpes and tooth infections) 7 5 reproductive infections (including vulvovaginal mycotic infection) 3 1 and the lymphatic system disorders anaemia 13 8 leucopaenia (including neutropaenia and agranulocytosis) 14 8 leucocystosis 1 0 thrombocytopenia 1 0 Metabolism and nutrition disorders lipids increased 17 8 uric acid increased 6 3 blood sodium abnormal 10 3 hypokalaemia 3 2 hypophosphotaemia 2 1 blood potassium increased 3 1 Nervous system disorders headache 14 8 Vascular disorders hypertension 6 3 flushing 2 1 Respiratory, thoracic and mediastinal disorders cough 7 6 Gastrointestinal disorders nausea and vomiting 12 11 abdominal pain 10 6 sicca syndrome 3 2 GI haemorrhage 2 1 Hepato-biliary disorders liver enzymes elevated 12 8 Skin and subcutaneous tissue disorders rash (including exfoliative rash) 14 7 pruritus 5 1 dermatitis (including eczema) 3 1 bruising (including purpura) 2 0 Musculoskeletal, connective tissue and bone disorders musculoskeletal pain 14 9 muscle spasms (including creatine phosphokinase increased) 5 4 Renal and urinary disorders haematuria 9 4 renal impairment 8 4
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