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Abecma · 4.5 · No interaction studies have been performed.
Eintrag öffnenAbecma · 4.5 · Some patients required tocilizumab or siltuximab and/or corticosteroid for the management of CRS (see section
Eintrag öffnenAbecma · 4.5 · The co-administration of agents known to inhibit T cell function has not been formally studied. The co-adminis
Eintrag öffnenAbecma · 4.5 · The safety of immunisation with live viral vaccines during or following treatment with Abecma has not been stu
Eintrag öffnenAbecma · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenAbecma · 4.8 · 13 Abecma infusion to data cutoff date) was 20.8 months. In KarMMa-3 (N = 225), the median duration of follow-
Eintrag öffnenAbecma · 4.8 · 14 Table 3. Adverse reactions observed in patients treated with Abecma
Eintrag öffnenAbecma · 4.8 · 15 System organ class Adverse reaction All grades frequency Musculoskeletal and Arthralgia Very common connect
Eintrag öffnenAbecma · 4.8 · 17 Reporting of suspected adverse reactions
Eintrag öffnenAbecma · 4.8 · Description of selected adverse reactions
Eintrag öffnenAbecma · 4.8 · Febrile neutropenia and infections In the pooled studies, infections occurred in 62.8% of patients. Grade 3 or
Eintrag öffnenAbecma · 4.8 · Grade 3 or 4 adverse reactions were more often observed within the initial 8 weeks post-infusion (93.2%) compa
Eintrag öffnenAbecma · 4.8 · Neurologic adverse reactions including ICANS In the pooled studies, of the 409 patients, independent of invest
Eintrag öffnenAbecma · 4.8 · Of the 353 patients in the KarMMa and KarMMa-3 studies, the most common manifestations of investigator identif
Eintrag öffnenAbecma · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenAbecma · 4.8 · Serious adverse reactions occurred in 57.2% of patients. The most common serious adverse reactions (≥ 5%) incl
Eintrag öffnenAbecma · 4.8 · System organ class Adverse reaction All grades frequency Infections and Infections – bacterial Very common inf
Eintrag öffnenAbecma · 4.8 · Table 3 summarises the adverse reactions observed in the clinical studies of 409 patients treated with Abecma
Eintrag öffnenAbecma · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenAbecma · 4.8 · The most common Grade 3 or 4 adverse reactions (≥ 5%) were neutropenia (77.3%), anaemia (50.9%), thrombocytope
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