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Abecma · 4.8 · 17 Reporting of suspected adverse reactions
Eintrag öffnenAbecma · 4.8 · Description of selected adverse reactions
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 · 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
Eintrag öffnenAbecma · 4.8 · The most common adverse reactions (≥ 20%) included CRS (84.6%), neutropenia (80.0%), anaemia (63.6%), thromboc
Eintrag öffnenAbevmy · 4.8 · 12 Table 1: Adverse reactions by frequency System organ Very common Common Rare Very rare Not known class Infe
Eintrag öffnenAbevmy · 4.8 · 14 Table 2: Severe adverse reactions by frequency
Eintrag öffnenAbevmy · 4.8 · 18 reactions ranged from 0.4% to 6.9% in bevacizumab treated patients, compared with up to 4.5% of patients in
Eintrag öffnenAbevmy · 4.8 · 19 Arterial thromboembolism An increased incidence of arterial thromboembolic reactions was observed in patien
Eintrag öffnenAbevmy · 4.8 · 22 Table 3: Adverse reactions reported in post-marketing setting MedDRA system organ Reactions (frequency*) cl
Eintrag öffnenAbevmy · 4.8 · Adverse reactions are added to the appropriate frequency category in the tables below according to the highest
Eintrag öffnenAbevmy · 4.8 · Bevacizumab use has been associated with serious cases of fistulae including reactions resulting in death.
Eintrag öffnenAbevmy · 4.8 · Description of selected serious adverse reactions
Eintrag öffnenAbevmy · 4.8 · Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated
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