Table 3.
Adverse events of special interest in the modified full analysis set (N = 62)
| Patients who received axi-cel (N = 62) | |
|---|---|
| CRS, n (%) | |
| Any | 58 (93.5) |
| Grade 1–2 | 53 (85.5) |
| Grade 3–4 | 5 (8.1) |
| Median time to onset (Q1–Q3), days | 1.5 (1.0–3.0) |
| Median duration (Q1–Q3), days | 5.0 (4.0–9.0) |
| ICANS, n (%) | |
| Any | 32 (51.6) |
| Grade 1–2 | 23 (37.1) |
| Grade 3–4 | 9 (14.5) |
| Median time to onset (Q1–Q3), days | 6.0 (5.0–8.0) |
| Median duration (Q1–Q3), days | 5.0 (3.0–8.0) |
| Grade ≥ 3 prolonged cytopeniaa, n (%) | 23 (37.1) |
| Grade ≥3 prolonged neutropenia | 15 (24.2) |
| Grade ≥3 prolonged anemia | 14 (22.6) |
| Grade ≥3 prolonged thrombocytopenia | 14 (22.6) |
| Use of tocilizumab to manage CAR-T cell toxicities, n (%) | 48 (77.4) |
| Use of corticosteroids to manage CAR-T cell toxicities, n (%) | 40 (64.5) |
| ICU transfer due to CAR-T cell toxicities, n (%) | 16 (25.8) |
| Infections, n (%) | |
| Any | 33 (53.2) |
| Grade 3–4 | 11 (17.7) |
| Grade 5 | 6 (9.7) |
| Nonrelapse mortality, n (%) | 6 (9.7) |
aGrade ≥3 prolonged cytopenia was defined as a grade ≥3 laboratory result of anemia, neutropenia and/or thrombocytopenia not resolved 30 days after axi-cel infusion. CAR, chimeric antigen receptor; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; ICU, intensive care unit; Q, quartile.