Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Vizimpro

Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 9–10

HOS-141919 · Präparat HOS-098712

Dacomitinib Gefitinib (N=227) (N=224) Adverse Reactionsa All Grades Grade 3 Grade 4 All Grades Grade 3 Grade 4 % % % % % % Metabolism and nutrition disorders Decreased appetite 30.8 3.1 0.0 25.0 0.4 0.0 Hypokalaemiab 10.1 4.0 0.9 5.8 1.8 0.0 Eye disorders Conjunctivitisc 23.3 0.0 0.0 8.9 0.0 0.0 Gastrointestinal disorders Diarrhoead 87.2 8.4 0.0 55.8 0.9 0.0 Stomatitise 69.6 4.4 0.4 33.5 0.4 0.0 Nausea 18.9 1.3 0.0 21.9 0.4 0.0 Skin and subcutaneous tissue disorders Rashf 77.1 24.2 0.0 57.6 0.9 0.0 Palmar-plantar 14.5 0.9 0.0 3.1 0.0 0.0 erythrodysaesthesia syndrome Dry sking 29.5 1.8 0.0 18.8 0.4 0.0 Pruritush 20.3 0.9 0.0 14.3 1.3 0.0 Nail disorderi 65.6 7.9 0.0 21.4 1.3 0.0 Alopecia 23.3 0.4 0.0 12.5 0.0 0.0 General disorders and administration site conditions Asthenia 12.8 2.2 0.0 12.5 1.3 0.0 Investigations Transaminases 23.8 0.9 0.0 40.2 9.8 0.0 increasedj Weight decreased 25.6 2.2 0.0 16.5 0.4 0.0 a Only adverse reactions with ≥ 10% incidence in the dacomitinib arm are included. b Hypokalaemia includes the following preferred terms (PTs): Blood potassium decreased, Hypokalaemia. c Conjunctivitis includes the following PTs: Blepharitis, Conjunctivitis, Dry eye, Noninfective conjunctivitis. d 1 fatal event was reported in the dacomitinib arm. e Stomatitis includes the following PTs: Aphthous ulcer, Cheilitis, Dry mouth, Mucosal inflammation, Mouth ulceration, Oral pain, Oropharyngeal pain, Stomatitis. f Rash includes the following PTs: Acne, Dermatitis acneiform, Erythema, Rash, Rash erythematous, Rash generalised, Rash macular, Rash maculo-papular, Rash papular. g Dry skin includes the following PTs: Dry skin, Xerosis. 9  Table 4. Very common adverse reactions in Phase 3 Study ARCHER 1050 (N=451)

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