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Ninlaro · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenNinlaro · 4.8 Undesirable effects · 1
Eintrag öffnenNinlaro · 4.8 · 10 Description of selected adverse reactions
Eintrag öffnenNinlaro · 4.8 · 11 The frequency of severe (Grade 3-4) events of hypokalaemia was higher in the ixazomib regimen (7%) than the
Eintrag öffnenNinlaro · 4.8 · 9 reactions first. Within each frequency grouping, adverse reactions are presented in order of decreasing seri
Eintrag öffnenNinlaro · 4.8 · As ixazomib is administered in combination with lenalidomide and dexamethasone, refer to the SmPC for these me
Eintrag öffnenNinlaro · 4.8 · Diarrhoea resulted in discontinuation of one or more of the three medicinal products in 2% of patients in the
Eintrag öffnenNinlaro · 4.8 · Discontinuations
Eintrag öffnenNinlaro · 4.8 · Eye disorders
Eintrag öffnenNinlaro · 4.8 · Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 34% in pat
Eintrag öffnenNinlaro · 4.8 · For each adverse reaction, one or more of the three medicinal products was discontinued in ≤ 3% of patients in
Eintrag öffnenNinlaro · 4.8 · Fungal and viral pneumonia resulting in fatal outcome were rarely reported in patients given the ixazomib, len
Eintrag öffnenNinlaro · 4.8 · Gastrointestinal toxicities
Eintrag öffnenNinlaro · 4.8 · In the pooled dataset from the pivotal, Phase 3, global C16010 study (n = 720) and the double-blind, placebo-c
Eintrag öffnenNinlaro · 4.8 · Other adverse reactions
Eintrag öffnenNinlaro · 4.8 · Peripheral neuropathy
Eintrag öffnenNinlaro · 4.8 · Peripheral neuropathy occurred in 28% of patients in the ixazomib regimen compared to 22% of patients in the p
Eintrag öffnenNinlaro · 4.8 · Rash occurred in 25% of patients in the ixazomib regimen compared to 15% of patients in the placebo regimen. T
Eintrag öffnenNinlaro · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenNinlaro · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
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