Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Talzenna

Talzenna 0.1 mg hard capsules Talzenna 0.25 mg hard capsules Talzenna 0.35 mg hard capsules Talzenna 0.5 mg hard capsules Talzenna 1 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9–10

HOS-140591 · Präparat HOS-098546

9 Table 4. Adverse reactions based on pooled dataset from 8 studies (N=1 088) System organ class All grades Grade 3 Grade 4 Frequency n (%) n (%) n (%) Preferred term Abdominal painh 162 (14.9) 12 (1.1) N/A Common Stomatitis 54 (5.0) 0 (0.0) 0 (0.0) Dyspepsia 69 (6.3) 0 (0.0) N/A Skin and subcutaneous tissue disorders Very common Alopecia 189 (17.4) N/A N/A General disorders and administration site conditions Very common Fatiguei 571 (52.5) 58 (5.3) N/A Abbreviations: n=number of patients; N/A=not applicable. * Grade 5 adverse reactions were reported. a. See also section 4.4. b. Includes preferred terms of thrombocytopenia and platelet count decreased. c. Includes preferred terms of anaemia, haematocrit decreased, haemoglobin decreased and red blood cell count decreased. d. Includes preferred terms of neutropenia and neutrophil count decreased. e. Includes preferred terms of leukopenia and white blood cell count decreased. f. Includes preferred terms of lymphocyte count decreased and lymphopenia. g Includes preferred terms of pulmonary embolism, deep vein thrombosis, embolism venous and venous thrombosis. See also section 4.4. h. Includes preferred terms of abdominal pain, abdominal pain upper, abdominal discomfort and abdominal pain lower. i. Includes preferred terms of fatigue and asthenia.

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