Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Giotrif

GIOTRIF 20 mg film-coated tablets GIOTRIF 30 mg film-coated tablets GIOTRIF 40 mg film-coated tablets GIOTRIF 50 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11

HOS-214122 · Präparat HOS-155264

GIOTRIF Gefitinib (40 mg/day) N = 160 N = 159 NCI-CTC Grade Any 3 4 Any 3 4 Grade Grade MedDRA Preferred Term % % % % % % Infections and infestations Paronychia1 57.5 1.9 0 17.0 0.6 0 2 Cystitis 11.3 1.3 0 7.5 1.3 0.6 Metabolism and nutrition disorders Decreased appetite 27.5 1.3 0 24.5 1.9 0 Hypokalaemia3 10.6 2.5 1.3 5.7 1.3 0 Respiratory, thoracic and mediastinal disorders Rhinorrhoea4 19.4 0 0 7.5 0 0 Epistaxis 18.1 0 0 8.8 0 0 Gastrointestinal disorders Diarrhoea 90.6 13.8 0.6 64.2 3.1 0 Stomatitis5 64.4 4.4 0 27.0 0 0 Nausea 25.6 1.3 0 27.7 1.3 0 Vomiting 19.4 0.6 0 13.8 2.5 0 Dyspepsia 10.0 0 0 8.2 0 0 Hepatobiliary disorders Alanine aminotransferase increased 11.3 0 0 27.7 8.8 0.6 Skin and subcutaneous tissue disorders Rash6 80.0 7.5 0 67.9 3.1 0 Dry skin 32.5 0 0 39.6 0 0 7 Pruritus 25.6 0 0 25.2 0 0 Dermatitis acneiform8 23.8 1.9 0 32.1 0.6 0 General disorders and administration site conditions Pyrexia 13.8 0 0 6.3 0 0 Investigations Weight decreased 10.0 0.6 0 5.7 0.6 0 1 Includes Paronychia, Nail infection, Nail bed infection 2 Includes Cystitis, Urinary tract infection 3 Includes Hypokalaemia, Blood potassium decreased 4 Includes Rhinorrhoea, Nasal inflammation 5 Includes Stomatitis, Aphthous stomatitis, Mucosal inflammation, Mouth ulceration, Mucosal erosion 6 Includes group of rash preferred terms 7 Includes Pruritus, Pruritus generalised 8 Includes Dermatitis acneiform, Acne

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