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Blitzima · 4.8 · During the overall study period, the safety profile of rituximab was consistent with that reported during the
Eintrag öffnenBlitzima · 4.8 · In GPA/MPA Study 1, at 6 months, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobul
Eintrag öffnenBlitzima · 4.8 · In GPA/MPA Study 2 (adult maintenance study), 7/57 (12%) patients in the rituximab arm experienced at least on
Eintrag öffnenBlitzima · 4.8 · In GPA/MPA Study 2, 30/57 (53%) patients in the rituximab arm experienced infections. The incidence of all gra
Eintrag öffnenBlitzima · 4.8 · In GPA/MPA Study 2, no clinically meaningful differences between the two treatment arms or decreases in total
Eintrag öffnenBlitzima · 4.8 · In GPA/MPA Study 2, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs. 5% for az
Eintrag öffnenBlitzima · 4.8 · In PV Study 2, 42 patients (62.7%) in the rituximab arm experienced infections. The most common infections in
Eintrag öffnenBlitzima · 4.8 · In PV Study 2, IRRs occurred primarily at the first infusion and the frequency of IRRs decreased with subseque
Eintrag öffnenBlitzima · 4.8 · In PV Study 2, a randomized, double-blind, double-dummy, active-comparator, multicenter study evaluating the e
Eintrag öffnenBlitzima · 4.8 · In PV Study 2, low IgG levels were commonly observed and low IgM levels were very commonly observed; however,
Eintrag öffnenBlitzima · 4.8 · In the paediatric clinical trial, during the overall study period, 3/25 (12%) patients reported an event of hy
Eintrag öffnenBlitzima · 4.8 · Infections In GPA/MPA Study 1, the overall rate of infection was approximately 237 per 100 patient years (95%
Eintrag öffnenBlitzima · 4.8 · Infusion-related reactions In GPA/MPA Study 1 (adult induction of remission study), IRRs were defined as any a
Eintrag öffnenBlitzima · 4.8 · Infusion-related reactions In PV Study 1, infusion-related reactions were common (58%). Nearly all infusion-re
Eintrag öffnenBlitzima · 4.8 · Laboratory abnormalities PV Study 2, in the rituximab arm, transient decreases in lymphocyte count, driven by
Eintrag öffnenBlitzima · 4.8 · Long-term follow-up (GPA/MPA Study 3) In a long-term observational safety study, 97 GPA and MPA patients recei
Eintrag öffnenBlitzima · 4.8 · Malignancies In GPA/MPA Study 1, the incidence of malignancy in rituximab treated patients in the GPA and MPA
Eintrag öffnenBlitzima · 4.8 · Neutropenia In GPA/MPA Study 1, 24% of patients in the rituximab group (single course) and 23% of patients in
Eintrag öffnenBlitzima · 4.8 · Paediatric population An open-label, single arm study was conducted in 25 paediatric patients with severe, act
Eintrag öffnenBlitzima · 4.8 · Summary of the safety profile in PV Study 1 (Study ML22196) and PV Study 2 (Study WA29330)
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