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