Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Retsevmo

Retsevmo 40 mg hard capsules Retsevmo 80 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17

HOS-146875 · Präparat HOS-099572

Elderly In patients receiving selpercatinib, 24.7% were ≥65-74 years of age, 8.6% were 75-84 years of age, and 1.0% ≥ 85 years of age in study LIBRETTO-001. In study LIBRETTO-431, 26.6% of patients receiving selpercatinib were ≥65-74 years of age, 9.5% were 75-84 years of age and 1.3% were ≥85 years of age. In study LIBRETTO-531, 20.2% of patients receiving selpercatinib were ≥65-74 years of age, 5.2% were 75-84 years of age and none were ≥85 years of age. The frequency of serious adverse events reported was higher in patients ≥65-74 years (58.0%), 75-84 years (62.5%), and ≥85 years (100.0%), than in patients <65 years (46.7%) of age in LIBRETTO-001 and in LIBRETTO-431, ≥65-74 years (38.1%), 75-84 years (46.7%), ≥85 years (50.0%), than in patients <65 years (31.3%) of age. In LIBRETTO-531 the frequency of serious adverse events reported was higher in patients 75-84 years (50%) than in patients <65 years (20.8%) and 65-74 years (17.9%). In study LIBRETTO-001 the frequency of adverse events (AE) leading to discontinuation of selpercatinib was higher in patients ≥65-74 years (10.1%), 75-84 years (19.4%), and ≥85 years

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