Nebenwirkungen · Rozlytrek
Rozlytrek 50 mg film-coated granules in sachet · Abschnitt 4.8 · PDF-Seite 50
HOS-143104 · Präparat HOS-098918
Adverse reactions and laboratory abnormalities of Grade 3 or 4 severity occurring more frequently (at least a 5% increased incidence) in paediatric patients compared to adult patients were neutropenia (19.8% vs 4.5%), weight increased (18.7% vs 9.6%), bone fractures (11% vs 2.5%), and lung infection (11% vs 5.5%). No Grade 5 events were observed in the 91 patients in the expanded paediatric safety population. Grade 3 to 4 events that occurred at a frequency ≥ 5% were neutropenia (19.8%), weight increased (18.7%), fractures (11%), lung infection (11%), and anaemia (8.8%).
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Version 2025-03-27T15:44:00Z · SHA-256 dd56cb496d4ec02972235ebd05e62294b444e36302865842fe46e147734ef2b5 · Passage d4d6192a208287a9c9ee52e7e3621650e0d3980e050c0f3dc82981902349a278 · Zeichen 31133–31710 im Abschnitt