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Ogsiveo · 4.5 · Since no study has been performed investigating the effect of nirogacestat on systemic contraceptive steroid e
Eintrag öffnenOgsiveo · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenOgsiveo · 4.8 Undesirable effects · 1
Eintrag öffnenOgsiveo · 4.8 · -- Represents no cases were reported. * From post marketing cases.
Eintrag öffnenOgsiveo · 4.8 · 10 (range 4 to 18 weeks). Effects of nirogacestat on fertility are unknown (see section 4.4). An exposure- res
Eintrag öffnenOgsiveo · 4.8 · 11 Reporting of suspected adverse reactions
Eintrag öffnenOgsiveo · 4.8 · 8 Permanent discontinuation of nirogacestat due to an adverse event occurred in 19% of patients. The most comm
Eintrag öffnenOgsiveo · 4.8 · 9 System organ class Adverse reaction All grades Grades 3-4 Respiratory, thoracic and Cough Very common -- med
Eintrag öffnenOgsiveo · 4.8 · Bone fracture In the double‑blind phase of the DeFi study, bone fractures were reported in 6% of patients rece
Eintrag öffnenOgsiveo · 4.8 · Description of selected adverse reactions
Eintrag öffnenOgsiveo · 4.8 · Diarrhoea In the double-blind phase of the DeFi study, diarrhoea was reported in 84% of patients receiving nir
Eintrag öffnenOgsiveo · 4.8 · Electrolyte abnormalities Electrolyte abnormalities were reported in patients receiving nirogacestat in the do
Eintrag öffnenOgsiveo · 4.8 · Epiphyseal disorder, manifesting as a widening of the epiphyseal growth plate, was reported in 4 of 26 (15%) p
Eintrag öffnenOgsiveo · 4.8 · Hepatic abnormalities ALT and AST elevations were reported in 19% and 17%, respectively, of patients receiving
Eintrag öffnenOgsiveo · 4.8 · Non-melanoma skin cancers Non-melanoma skin cancers were reported at a higher incidence in patients receiving
Eintrag öffnenOgsiveo · 4.8 · Ovarian toxicity In the double‑blind phase of the DeFi study, 75% of women of childbearing potential receiving
Eintrag öffnenOgsiveo · 4.8 · Paediatric population
Eintrag öffnenOgsiveo · 4.8 · Proximal renal tubule effect Glycosuria and proteinuria were observed in 52% and 46%, respectively, of patient
Eintrag öffnenOgsiveo · 4.8 · Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows con
Eintrag öffnenOgsiveo · 4.8 · Skin and subcutaneous tissue disorders In the double‑blind phase of the DeFi study, dermatologic reactions wer
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