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Litfulo · 4.8 · A total of 1630 patients were treated with ritlecitinib representing 3751 patient-years of exposure. Three pla
Eintrag öffnenLitfulo · 4.8 · A total of 181 adolescents (12 to < 18 years of age) were enrolled in ritlecitinib alopecia areata studies.
Eintrag öffnenLitfulo · 4.8 · Creatine phosphokinase (CPK) elevations In the placebo-controlled studies, for up to 24 weeks, events of blood
Eintrag öffnenLitfulo · 4.8 · Decreased lymphocyte count In the placebo-controlled studies, for up to 24 weeks, and study AA-I, for up to 48
Eintrag öffnenLitfulo · 4.8 · Decreased platelet count In the placebo-controlled studies, for up to 24 weeks, and study AA-I, for up to 48 w
Eintrag öffnenLitfulo · 4.8 · Description of selected adverse reactions
Eintrag öffnenLitfulo · 4.8 · In the placebo-controlled studies the percentage of patients reporting infection-related adverse reaction of h
Eintrag öffnenLitfulo · 4.8 · In the placebo-controlled studies, for up to 24 weeks, no serious infections were reported in patients treated
Eintrag öffnenLitfulo · 4.8 · Increased transaminases In the placebo-controlled studies, for up to 24 weeks, events of increases in ALT and
Eintrag öffnenLitfulo · 4.8 · Infections In the placebo-controlled studies, for up to 24 weeks, overall infections have been reported in 31%
Eintrag öffnenLitfulo · 4.8 · Opportunistic infections Opportunistic infections of multi-dermatomal herpes zoster were reported in 1 patient
Eintrag öffnenLitfulo · 4.8 · Paediatric population
Eintrag öffnenLitfulo · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenLitfulo · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenLitfulo · 4.8 · Summary of the safety profile
Eintrag öffnenLitfulo · 4.8 · Table 2 lists all adverse reactions observed in alopecia areata placebo-controlled studies presented by system
Eintrag öffnenLitfulo · 4.8 · Table 2. Adverse reactions System organ class Common Uncommon Infections and infestations Herpes zoster Follic
Eintrag öffnenLitfulo · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenLitfulo · 4.8 · The most frequently reported adverse reactions are diarrhoea (9.2%), acne (6.2%), upper respiratory tract infe
Eintrag öffnenLitfulo · 4.8 · The safety profile observed in adolescents was similar to that of the adult population.
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