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Elzonris · 4.8 · Hypersensitivity Reactions representative of hypersensitivity were reported in 19% (33/176) of patients treate
Eintrag öffnenElzonris · 4.8 · Immunogenicity Immune response was evaluated by assessment of serum binding reactivity against tagraxofusp (an
Eintrag öffnenElzonris · 4.8 · In 190 patients treated with ELZONRIS in four clinical studies:
Eintrag öffnenElzonris · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenElzonris · 4.8 · Summary of the safety profile
Eintrag öffnenElzonris · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenElzonris · 4.8 · The adverse reaction frequency is listed by MedDRA System Organ Class (SOC) at the preferred term level. Frequ
Eintrag öffnenElzonris · 4.8 · The adverse reactions described in this section were identified in clinical studies of patients with haematolo
Eintrag öffnenElzonris · 4.8 · The most serious adverse reaction that may occur during ELZONRIS treatment is CLS (see sections 4.2 and 4.4) w
Eintrag öffnenElzonris · 4.8 · • 100% (N=170) of patients evaluable for treatment-emergent ADA tested positive with most patients showing an
Eintrag öffnenElzonris · 4.8 · • 74% (93/126) of patients who tested positive for anti-IL-3 antibodies and were evaluable for the presence of
Eintrag öffnenElzonris · 4.8 · • 75% (129/171) of patients evaluable for treatment-emergent anti-IL-3 antibodies tested positive with most pa
Eintrag öffnenElzonris · 4.8 · • 92% (155/169) of ADA-positive patients evaluable for the presence of neutralising antibodies post-treatment
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