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Ogsiveo 50 mg film‑coated tablets Ogsiveo 100 mg film‑coated tablets Ogsiveo 150 mg film‑coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-151377 · Präparat HOS-100527
Electrolyte abnormalities Electrolyte abnormalities were reported in patients receiving nirogacestat in the double‑blind phase of the DeFi study, including hypophosphataemia (43%) and hypokalaemia (12%), compared to 7% and 1%, respectively, in patients receiving placebo. Median time to first onset of hypophosphataemia and hypokalaemia was 15 days (range 1 to 833 days) and 15 days (range 1 to 57 days), respectively. Grade 3 events of hypophosphataemia and hypokalaemia occurred in 3% of patients receiving nirogacestat compared to no patients receiving placebo (see section 4.4). Hypophosphataemia and hypokalaemia led to dose reduction in 4% and 1% of patients receiving nirogacestat, respectively. Hypophosphataemia led to dose discontinuation in 1% of patients receiving nirogacestat.
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