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Aucatzyl · 4.8 · Description of selected adverse reactions
Eintrag öffnenAucatzyl · 4.8 · Fatal infections of unspecified pathogen were reported in 0.8% of patients. Fatal sepsis occurred in 3.9% of p
Eintrag öffnenAucatzyl · 4.8 · Grade 3 or higher febrile neutropenia was observed in 23.6% of patients after Aucatzyl infusion and may be con
Eintrag öffnenAucatzyl · 4.8 · Grade ≥ 3 cytopenias at month 1 following infusion were observed in 68.5% of patients and included neutropenia
Eintrag öffnenAucatzyl · 4.8 · HLH/MAS, including severe and life-threatening reactions may occur following treatment with Aucatzyl. HLH/MAS
Eintrag öffnenAucatzyl · 4.8 · Haemophagocytic lymphohistiocytosis (HLH)/ macrophage activation syndrome (MAS)
Eintrag öffnenAucatzyl · 4.8 · Hypogammaglobulinaemia
Eintrag öffnenAucatzyl · 4.8 · Hypogammaglobulinaemia was reported in 9.4% of patients, treated with Aucatzyl including 2 cases (1.6%) of gra
Eintrag öffnenAucatzyl · 4.8 · ICANS was reported in 29 patients (22.8%). Grade ≥ 3 ICANS occurred in 9 patients (7.1%) following treatment w
Eintrag öffnenAucatzyl · 4.8 · Immune effector cell-associated neurotoxicity syndrome
Eintrag öffnenAucatzyl · 4.8 · Immunogenicity
Eintrag öffnenAucatzyl · 4.8 · In the FELIX study, 80% of patients who experienced CRS had ≥ 5% blasts in their BM at the time of lymphodeple
Eintrag öffnenAucatzyl · 4.8 · In the FELIX study, most patients who experienced ICANS (89.7%) and all patients who experienced grade ≥ 3 ICA
Eintrag öffnenAucatzyl · 4.8 · Infections
Eintrag öffnenAucatzyl · 4.8 · Infections following Aucatzyl infusion (all grades) occurred in 70.9% of patients. Grade 3 or 4 non-COVID-19 i
Eintrag öffnenAucatzyl · 4.8 · Prolonged cytopenia
Eintrag öffnenAucatzyl · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAucatzyl · 4.8 · Secondary malignancies
Eintrag öffnenAucatzyl · 4.8 · Summary of the safety profile
Eintrag öffnenAucatzyl · 4.8 · Table 4 summarises the adverse reactions in a total of 127 patients exposed to Aucatzyl in the Phase Ib and Ph
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