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20 angezeigte Treffer · Seite 3, keine Gesamtzahl für „Tecfidera“
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Begriffe & Kennungen
Tecfidera · 4.8 · In a 96-week open-label, randomised active controlled trial paediatric patients with RRMS (n=7 aged 10 to less
Eintrag öffnenTecfidera · 4.8 · In a small 24-week open-label uncontrolled study in paediatric patients with RRMS aged 13 to 17 years (120 mg
Eintrag öffnenTecfidera · 4.8 · In addition, in an uncontrolled, prospective, post-marketing study, at week 48 of treatment with Tecfidera (n=
Eintrag öffnenTecfidera · 4.8 · In clinical studies (both controlled and uncontrolled), 41% of patients treated with Tecfidera had lymphopenia
Eintrag öffnenTecfidera · 4.8 · In phase 2 and 3 placebo-controlled and uncontrolled clinical studies, a total of 2,513 patients have received
Eintrag öffnenTecfidera · 4.8 · In several PML cases with determination of T cell subsets at the time of diagnosis of PML, CD8+ T cell counts
Eintrag öffnenTecfidera · 4.8 · In the placebo-controlled studies, measurement of urinary ketones (1+ or greater) was higher in patients treat
Eintrag öffnenTecfidera · 4.8 · In the placebo-controlled studies, most patients (> 98%) had normal lymphocyte counts prior to initiating trea
Eintrag öffnenTecfidera · 4.8 · In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was
Eintrag öffnenTecfidera · 4.8 · Increase of liver enzymes and cases of drug-induced liver injury (elevations in transaminases ≥ 3 times ULN wi
Eintrag öffnenTecfidera · 4.8 · Laboratory abnormalities
Eintrag öffnenTecfidera · 4.8 · Levels of 1,25-dihydroxyvitamin D decreased in Tecfidera treated patients relative to placebo (median percenta
Eintrag öffnenTecfidera · 4.8 · Lymphopenia
Eintrag öffnenTecfidera · 4.8 · MedDRA system organ class Adverse reaction Frequency category Infections and infestations Gastroenteritis Comm
Eintrag öffnenTecfidera · 4.8 · Paediatric population
Eintrag öffnenTecfidera · 4.8 · Progressive multifocal leukoencephalopathy (PML)
Eintrag öffnenTecfidera · 4.8 · Prolonged moderate to severe lymphopenia appears to increase the risk of PML with Tecfidera. However, PML also
Eintrag öffnenTecfidera · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenTecfidera · 4.8 · Summary of the safety profile
Eintrag öffnenTecfidera · 4.8 · Tabulated list of adverse reactions
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