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Jyseleca · 4.8 · Across the two placebo-controlled induction studies, the frequency of serious infections was 0.6% in the filgo
Eintrag öffnenJyseleca · 4.8 · Creatine phosphokinase Dose-dependent increases in creatine phosphokinase (CPK) occurred within the first 12 w
Eintrag öffnenJyseleca · 4.8 · Creatinine An increase in serum creatinine occurred with filgotinib treatment. At week 24 in the Phase 3 studi
Eintrag öffnenJyseleca · 4.8 · Description of selected adverse reactions
Eintrag öffnenJyseleca · 4.8 · Experience from long-term extension studies
Eintrag öffnenJyseleca · 4.8 · Frequency a Adverse reaction Infections and infestations Common Urinary tract infection (UTI) Upper respirator
Eintrag öffnenJyseleca · 4.8 · In placebo-controlled Phase 3 studies with background DMARDs (FINCH 1 and FINCH 2) through 12 weeks, CPK eleva
Eintrag öffnenJyseleca · 4.8 · In placebo-controlled Phase 3 studies with background DMARDs (FINCH 1 and FINCH 2) through 12 weeks, serum pho
Eintrag öffnenJyseleca · 4.8 · In placebo-controlled studies with background DMARDs, the frequencies of infectious ADRs over 12 weeks for fil
Eintrag öffnenJyseleca · 4.8 · In placebo-controlled studies with background DMARDs, the frequency of serious infection over 12 weeks in the
Eintrag öffnenJyseleca · 4.8 · Infections
Eintrag öffnenJyseleca · 4.8 · Laboratory changes
Eintrag öffnenJyseleca · 4.8 · Lipids Treatment with filgotinib was associated with dose-dependent increases in total cholesterol and HDL lev
Eintrag öffnenJyseleca · 4.8 · Nausea Nausea was generally transient and reported during the first 24 weeks of filgotinib treatment.
Eintrag öffnenJyseleca · 4.8 · Opportunistic infections (excluding TB) In rheumatoid arthritis placebo-controlled studies with background DMA
Eintrag öffnenJyseleca · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenJyseleca · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenJyseleca · 4.8 · Rheumatoid arthritis In placebo-controlled studies with background DMARDs (FINCH 1, FINCH 2, DARWIN 1, and DAR
Eintrag öffnenJyseleca · 4.8 · Rheumatoid arthritis In the long-term extension study DARWIN 3, patients enrolled from DARWIN 1 (N = 497) rece
Eintrag öffnenJyseleca · 4.8 · Rheumatoid arthritis The most frequently reported adverse reactions are nausea (3.5%), upper respiratory tract
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