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Nulojix · 4.8 · Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3
Eintrag öffnenNulojix · 4.8 · Autoimmunity In newly transplanted patient studies, the occurrence of autoimmune events across the core clinic
Eintrag öffnenNulojix · 4.8 · Conversion Studies 1 and 2 The overall safety profile of belatacept in the two conversion studies was consiste
Eintrag öffnenNulojix · 4.8 · Description of selected adverse reactions
Eintrag öffnenNulojix · 4.8 · During the long-term extension period in newly transplanted patient trials, serious infections occurred in 30.
Eintrag öffnenNulojix · 4.8 · During the long-term extension period, autoimmune events occurred in 2.6% and 3.0% of patients in the belatace
Eintrag öffnenNulojix · 4.8 · During the long-term extension period, malignancies (including PTLD) were reported in 10.3%, 8.4%, and 14.7% o
Eintrag öffnenNulojix · 4.8 · EBV seronegative patients receiving immunosuppressants are at a particularly increased risk for PTLD (see sect
Eintrag öffnenNulojix · 4.8 · Graft thrombosis In a Phase 3 study in newly transplanted recipients of extended criteria donor (ECD) kidneys
Eintrag öffnenNulojix · 4.8 · Immunogenicity Antibodies directed against the belatacept molecule were assessed in 796 kidney transplant reci
Eintrag öffnenNulojix · 4.8 · In newly transplanted patient studies, acute infusion-related reactions (reactions occurring within one hour o
Eintrag öffnenNulojix · 4.8 · In the 3 newly transplanted patient studies (one Phase 2 and two Phase 3 studies, Study 1 and Study 2), the cu
Eintrag öffnenNulojix · 4.8 · In trials conducted to support use in newly transplanted patients, the most common serious adverse reactions (
Eintrag öffnenNulojix · 4.8 · Infections In newly transplanted patient trials, Year 1 and Year 3 frequencies of infections occurring by trea
Eintrag öffnenNulojix · 4.8 · Infections involving the CNS were more frequent in the belatacept MI group (8 cases, including the PML case di
Eintrag öffnenNulojix · 4.8 · Infusion-related reactions Anaphylaxis has been reported post marketing(see section 4.4).
Eintrag öffnenNulojix · 4.8 · Long-term extension in Study 1 and Study 2 Of the 1209 randomised and newly transplanted patients in the two P
Eintrag öffnenNulojix · 4.8 · Malignancies and post-transplant lymphoproliferative disease In the newly transplanted patient trials, Year 1
Eintrag öffnenNulojix · 4.8 · Presented in Table 2, by system organ classification and frequency categories, is the list of adverse reaction
Eintrag öffnenNulojix · 4.8 · Reporting of suspected adverse reactions
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