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Gazyvaro · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenGazyvaro · 4.8 · Short Duration Infusion in patients with Follicular Lymphoma
Eintrag öffnenGazyvaro · 4.8 · Special populations
Eintrag öffnenGazyvaro · 4.8 · Summary of the safety profile
Eintrag öffnenGazyvaro · 4.8 · System Organ Class All Grades Grades 3-5 Frequency Infections and infestations Very common Upper respiratory t
Eintrag öffnenGazyvaro · 4.8 · System organ class All Grades Grades 3-5† Frequency Gazyvaro + chemotherapy* Gazyvaro + chemotherapy* (CLL, iN
Eintrag öffnenGazyvaro · 4.8 · Table 10 Summary of ADRs reported in patients# receiving Gazyvaro + chemotherapy*
Eintrag öffnenGazyvaro · 4.8 · Table 10 summarises all ADRs including those of the pivotal studies (BO21004/CLL11, BO21223/GALLIUM GAO4753g/G
Eintrag öffnenGazyvaro · 4.8 · Table 11 Study MO40597/GAZELLE Short-Duration Infusion: Infusion Related Reactionsa by Cycle (Safety-Evaluable
Eintrag öffnenGazyvaro · 4.8 · Table 12 ADRs reported in patients receiving Gazyvaro + standard therapy* in LN
Eintrag öffnenGazyvaro · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenGazyvaro · 4.8 · The ADRs listed in Table 12 are based on pooled safety data from two clinical studies in patients with ISN/RPS
Eintrag öffnenGazyvaro · 4.8 · The adverse drug reactions (ADRs) from clinical trials were identified during induction, maintenance and follo
Eintrag öffnenGazyvaro · 4.8 · The incidence of IRRs was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab plus chloramb
Eintrag öffnenGazyvaro · 4.8 · The incidence of neutropenia was higher in the Gazyvaro plus chlorambucil arm (41%) compared to the rituximab
Eintrag öffnenGazyvaro · 4.8 · The incidence of thrombocytopenia was 15%. Thrombocytopenia occurred more frequently in Cycle 1 in the Gazyvar
Eintrag öffnenGazyvaro · 4.8 · The incidence of thrombocytopenia was higher in the Gazyvaro plus chlorambucil arm compared to the rituximab p
Eintrag öffnenGazyvaro · 4.8 · The incidences presented in the following sections if referring to iNHL are the highest incidence of that ADR
Eintrag öffnenGazyvaro · 4.8 · The population pharmacokinetic analysis (n = 196) of Gazyvaro showed that creatinine clearance does not affect
Eintrag öffnenGazyvaro · 4.8 · The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both s
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