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Yescarta · 4.8 · DLBCL and HGBL that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunot
Eintrag öffnenYescarta · 4.8 · Febrile neutropenia and infections Febrile neutropenia was observed in 10% of patients after Yescarta infusion
Eintrag öffnenYescarta · 4.8 · Follicular lymphoma after three or more lines of systemic therapy Safety data from ZUMA-5 reflects exposure to
Eintrag öffnenYescarta · 4.8 · Hypogammaglobulinaemia Hypogammaglobulinaemia was reported in 15% of patients treated with Yescarta. Cumulativ
Eintrag öffnenYescarta · 4.8 · Immunogenicity
Eintrag öffnenYescarta · 4.8 · In ZUMA-5, CRS occurred in 77% of patients. Six percent (6%) of patients experienced Grade 3 or higher (severe
Eintrag öffnenYescarta · 4.8 · In ZUMA-5, neurologic adverse reactions occurred in 57% of patients. Sixteen percent (16%) of patients experie
Eintrag öffnenYescarta · 4.8 · In registries, the cerebral oedema event rate in the PMBCL indication was 1.6% overall (2 cases in 129 exposed
Eintrag öffnenYescarta · 4.8 · Neurologic adverse reactions In ZUMA-1 and ZUMA-7, neurologic adverse reactions occurred in 63% of patients. T
Eintrag öffnenYescarta · 4.8 · Other neurologic adverse reactions have been reported less frequently in clinical trials and included dysphagi
Eintrag öffnenYescarta · 4.8 · Prolonged cytopenias Grade 3 or higher neutropenia (including febrile neutropenia), anaemia, and thrombocytope
Eintrag öffnenYescarta · 4.8 · Relapsed or refractory DLBCL, PMBCL and DLBCL arising from follicular lymphoma after two or more lines of syst
Eintrag öffnenYescarta · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenYescarta · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenYescarta · 4.8 · See section 4.4 for monitoring and management guidance.
Eintrag öffnenYescarta · 4.8 · Serious adverse reactions occurred in 51% of patients. The most common (≥ 5%) serious adverse reactions includ
Eintrag öffnenYescarta · 4.8 · Serious adverse reactions occurred in 54% of patients. The most common (≥ 5%) serious adverse reactions includ
Eintrag öffnenYescarta · 4.8 · Special population
Eintrag öffnenYescarta · 4.8 · Summary of the safety profile
Eintrag öffnenYescarta · 4.8 · System Organ Class (SOC) Frequency Adverse reactions Infections and infestations Very common Unspecified patho
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