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Riximyo · 4.8 · Hepatitis-B reactivation A small number of cases of hepatitis-B reactivation, some with fatal outcome, have be
Eintrag öffnenRiximyo · 4.8 · Hypogammaglobulinaemia Hypogammaglobulinaemia (IgA, IgG or IgM below the lower limit of normal) has been obser
Eintrag öffnenRiximyo · 4.8 · IgG levels In the clinical trial evaluating rituximab maintenance treatment in relapsed/refractory follicular
Eintrag öffnenRiximyo · 4.8 · In GPA/MPA Study 1, at 6 months, in the rituximab group, 27%, 58% and 51% of patients with normal immunoglobul
Eintrag öffnenRiximyo · 4.8 · In GPA/MPA Study 2 (adult maintenance study), 7/57 (12%) patients in the rituximab arm experienced at least on
Eintrag öffnenRiximyo · 4.8 · In GPA/MPA Study 2, 30/57 (53%) patients in the rituximab arm experienced infections. The incidence of all gra
Eintrag öffnenRiximyo · 4.8 · In GPA/MPA Study 2, no clinically meaningful differences between the two treatment arms or decreases in total
Eintrag öffnenRiximyo · 4.8 · In GPA/MPA Study 2, the incidence of all-grade neutropenia was 0% for rituximab-treated patients vs 5% for aza
Eintrag öffnenRiximyo · 4.8 · In PV Study 2, 42 patients (62.7%) in the rituximab arm experienced infections. The most common infections in
Eintrag öffnenRiximyo · 4.8 · In PV Study 2, a randomised, double-blind, double-dummy, active-comparator, multicentre study evaluating the e
Eintrag öffnenRiximyo · 4.8 · In PV Study 2, low IgG levels were commonly observed and low IgM levels were very commonly observed; however,
Eintrag öffnenRiximyo · 4.8 · In a trial designed to evaluate the safety of a more rapid rituximab infusion in patients with rheumatoid arth
Eintrag öffnenRiximyo · 4.8 · In patients with non-Hodgkin’s lymphoma receiving rituximab in combination with cytotoxic chemotherapy, cases
Eintrag öffnenRiximyo · 4.8 · In placebo-controlled periods of clinical trials, 0.94% (13/1 382) of rituximab treated patients and 0.27% (2/
Eintrag öffnenRiximyo · 4.8 · In studies of rituximab in patients with Waldenstrom’s macroglobulinaemia, transient increases in serum IgM le
Eintrag öffnenRiximyo · 4.8 · In the clinical trial in paediatric patients with GPA or MPA, the reported IRRs were predominantly seen with t
Eintrag öffnenRiximyo · 4.8 · In the clinical trial in paediatric patients with severe, active GPA and MPA, 91% of reported infections were
Eintrag öffnenRiximyo · 4.8 · In the paediatric clinical trial, no malignancies were reported with a follow-up period of up to 54 months.
Eintrag öffnenRiximyo · 4.8 · In the post marketing setting, serious viral infections have been reported in GPA/MPA patients treated with ri
Eintrag öffnenRiximyo · 4.8 · In the post marketing setting, serious viral infections have been reported in PV patients treated with rituxim
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