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Carvykti · 4.8 · Hypogammaglobulinaemia In the pooled studies (N=396), hypogammaglobulinaemia occurred in 34% of patients, with
Eintrag öffnenCarvykti · 4.8 · Immune effector cell-associated neurotoxicity syndrome (ICANS) In the pooled studies (N=396), ICANS occurred i
Eintrag öffnenCarvykti · 4.8 · Immunogenicity The immunogenicity of CARVYKTI has been evaluated using a validated assay for the detection of
Eintrag öffnenCarvykti · 4.8 · Movement and neurocognitive toxicity with signs and symptoms of parkinsonism Of the 90 patients in the pooled
Eintrag öffnenCarvykti · 4.8 · Neurologic toxicities Neurologic toxicity occurred in 23% of patients (n=90); 6% (n=22) of patients had Grade
Eintrag öffnenCarvykti · 4.8 · Of the 196 patients in Study MMY3002, 20 patients who had higher risk disease progressed early and rapidly on
Eintrag öffnenCarvykti · 4.8 · Peripheral neuropathy In the pooled studies (N=396), 28 patients developed peripheral neuropathy, presenting a
Eintrag öffnenCarvykti · 4.8 · Prolonged and recurrent cytopenias Grade 3 or 4 cytopenias at Day 1 after dosing, not resolved to Grade 2 or l
Eintrag öffnenCarvykti · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
Eintrag öffnenCarvykti · 4.8 · Serious adverse reactions occurred in 44% of patients; serious adverse reactions reported in ≥2% of patients w
Eintrag öffnenCarvykti · 4.8 · Serious infections Infections occurred in 54% of patients (n=213); 18% of patients (n=73) experienced Grade 3
Eintrag öffnenCarvykti · 4.8 · Summary of the safety profile The safety of CARVYKTI was evaluated in 396 adult patients with multiple myeloma
Eintrag öffnenCarvykti · 4.8 · Table 4: Adverse reaction in patients with multiple myeloma treated with CARVYKTI Incidence (%) All grade ≥ Sy
Eintrag öffnenCarvykti · 4.8 · Table 5 lists the incidences of Grade 3 or Grade 4 cytopenias occurring after dosing not resolved to Grade 2 o
Eintrag öffnenCarvykti · 4.8 · Table 5: Incidences of prolonged and recurrent cytopenias following treatment with CARVYKTI (N=396) Initial Gr
Eintrag öffnenCarvykti · 4.8 · Tabulated list of adverse reactions Table 4 summarises the adverse reactions that occurred in patients receivi
Eintrag öffnenCarvykti · 4.8 · The most common (≥20%) Grade ≥3 haematological abnormalities were neutropenia (89%), thrombocytopenia (45%), a
Eintrag öffnenCarvykti · 4.8 · The most common CARVYKTI adverse reactions (≥20%) were neutropenia (90%), pyrexia (85%), CRS (83%), thrombocyt
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