Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · MabThera

MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 29

HOS-087643 · Präparat HOS-083527

The adverse reactions from PV Studies 1 and 2 with a frequency categorisation of "common" or "very common" are presented in Table 7. In PV Study 1, adverse reactions were defined as adverse events which occurred at a rate of ≥ 5% among MabThera-treated PV patients, with a ≥ 2% absolute difference in incidence between the MabThera-treated group and the standard-dose prednisone group up to Month 24. No patients were withdrawn due to adverse reactions in Study 1. In PV Study 2, adverse reactions were defined as adverse events occurring in ≥ 5% of patients in the MabThera arm and assessed as related.

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