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. 2021 Oct 1;27(1):213–223. doi: 10.1007/s10147-021-02033-4

Table 4.

Late-onset and prolonged cytopenias (safety analysis set; n = 16)

Adverse event
Preferred term
Any grade, n (%) Grade ≥ 3, n (%)
Late-onset cytopeniasa
 Thrombocytopeniab 12 (75.0) 10 (62.5)
 Neutropeniac 11 (68.8) 11 (68.8)
 Anemia 5 (31.3) 4 (25.0)
 Febrile neutropenia 2 (12.5) 2 (12.5)
Prolonged cytopeniasd
 Neutropeniac 3 (18.8) 3 (18.8)
 Thrombocytopeniab 1 (6.3) 0 (0.0)
 Anemia 1 (6.3) 0 (0.0)

Coded with MedDRA version 21.0

axi-cel axicabtagene ciloleucel, MedDRA Medical Dictionary for Regulatory Activities

aLate-onset cytopenias were defined as any cytopenias present on or after 30 days of axi-cel infusion, including those that started after 30 days from axi-cel infusion and those that started earlier but were ongoing on or after 30 days of axi-cel infusion

bThrombocytopenia includes thrombocytopenia and platelet count decreased

cNeutropenia includes neutropenia and neutrophil count decreased

dProlonged cytopenias were defined as any cytopenias with duration ≥ 30 days or any consecutive events of cytopenias with a combined duration ≥ 30 days