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Polivy · 4.8 · Gastrointestinal toxicity In a placebo-controlled study GO39942 (POLARIX), gastrointestinal toxicity events we
Eintrag öffnenPolivy · 4.8 · Hepatic toxicity In a placebo-controlled study GO39942 (POLARIX), hepatic toxicity was reported in 10.6% of pa
Eintrag öffnenPolivy · 4.8 · In an open-label study GO29365, 4% of patients in the Polivy plus BR arms discontinued Polivy due to neutropen
Eintrag öffnenPolivy · 4.8 · In an open-label study GO29365, gastrointestinal toxicity events were reported in 72.8% of patients in the Pol
Eintrag öffnenPolivy · 4.8 · In an open-label study GO29365, in the Polivy plus BR arms, Grade 1 PN and Grade 2 PN were reported in 15.9% a
Eintrag öffnenPolivy · 4.8 · In an open-label study GO29365, one case of PML, which was fatal, occurred in one patient treated with Polivy
Eintrag öffnenPolivy · 4.8 · In another study, two cases of serious hepatic toxicity (hepatocellular injury and hepatic steatosis) were rep
Eintrag öffnenPolivy · 4.8 · In previously treated DLBCL patients treated with Polivy plus BR: The most frequently reported (≥ 30%) ADRs
Eintrag öffnenPolivy · 4.8 · In previously untreated DLBCL patients treated with Polivy plus R-CHP: The most frequently-reported (≥ 30%)
Eintrag öffnenPolivy · 4.8 · Infections In a placebo-controlled study GO39942 (POLARIX), infections, including pneumonia and other types of
Eintrag öffnenPolivy · 4.8 · Infections and infestations Very common pneumoniaa, upper respiratory tract infection Common sepsisa, herpes v
Eintrag öffnenPolivy · 4.8 · Myelosuppression In a placebo-controlled study GO39942 (POLARIX), 0.5% of patients in the Polivy plus R-CHP ar
Eintrag öffnenPolivy · 4.8 · Peripheral neuropathy (PN) In a placebo-controlled study GO39942 (POLARIX), in the Polivy plus R-CHP arm, Grad
Eintrag öffnenPolivy · 4.8 · Progressive multifocal leukoencephalopathy (PML) In a placebo-controlled study GO39942 (POLARIX), no cases of
Eintrag öffnenPolivy · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenPolivy · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenPolivy · 4.8 · Summary of the safety profile
Eintrag öffnenPolivy · 4.8 · Table 4 Tabulated list of ADRs in patients treated with Polivy in clinical trials
Eintrag öffnenPolivy · 4.8 · Tabulated list of ADRs from clinical trials
Eintrag öffnenPolivy · 4.8 · The ADRs in 586 patients treated with Polivy are presented in Table 4. The ADRs are listed below by MedDRA sys
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