Safety outcomes across age groups
| . | All patients (N = 703) . | ≥18 years (n = 209) . | <18 years (n = 494) . | <3 years (n = 54) . |
|---|---|---|---|---|
| CRS∗ | ||||
| All grade | 404 (57.5) | 131 (62.7) | 273 (55.3) | 33 (61.1) |
| Grade ≥3 | 115 (16.4) | 36 (17.2) | 79 (16.0) | 4 (7.4) |
| Median time to onset (range), d | 5 (1-38) | 5 (1-38) | 5 (1-24) | 6 (1-11) |
| Median duration (95% CI), d | 6 (6-7) | 6 (5-8) | 6 (6-7) | 5 (3-7) |
| Therapies | 245 (60.6) | 86 (65.6) | 159 (58.2) | 19 (57.6) |
| Corticosteroids | 62 (15.3) | 26 (19.8) | 36 (13.2) | 3 (9.1) |
| Siltuximab | 21 (5.2) | 7 (5.3) | 14 (5.1) | 2 (6.1) |
| Tocilizumab | 214 (53.0) | 78 (59.5) | 136 (49.8) | 14 (42.4) |
| Resolution | 381 (94.3) | 128 (97.7) | 253 (92.7) | 30 (90.9) |
| Death† | 3 (0.4) | 0 | 3 (0.6) | 0 |
| ICANS∗ | ||||
| All grade | 156 (22.2) | 47 (22.5) | 109 (22.1) | 7 (13.0) |
| Grade ≥3 | 63 (9.0) | 18 (8.6) | 45 (9.1) | 5 (9.3) |
| Median time to onset (range), d | 7 (1-93) | 8 (1-33) | 7 (2-93) | 6 (3-12) |
| Median duration (95% CI), d | 7 (6-8) | 7 (4-9) | 7 (5-8) | 7 (3-8) |
| Therapies | 106 (67.9) | 38 (80.9) | 68 (62.4) | 4 (57.1) |
| Antiepileptics | 53 (34.0) | 18 (38.3) | 35 (32.1) | 3 (42.9) |
| Corticosteroids | 47 (30.1) | 20 (42.6) | 27 (24.8) | 2 (28.6) |
| Siltuximab | 3 (1.9) | 1 (2.1) | 2 (1.8) | 0 |
| Tocilizumab | 24 (15.4) | 10 (21.3) | 14 (12.8) | 1 (14.3) |
| Resolution | 142 (91.0) | 44 (93.6) | 98 (89.9) | 7 (16.3) |
| Death† | 1 (0.1) | 1 (0.5) | 0 | 0 |
| Other outcomes of interest | ||||
| Prolonged neutropenia‡ | 152 (21.6) | 60 (28.7) | 92 (18.6) | 12 (22.2) |
| Duration, median (95% CI), d | 55 (48-60) | 57 (45-61) | 53 (44-60) | 63 (33 to NE) |
| Recovery§ | 102 (67.1) | 40 (66.7) | 62 (67.4) | 7 (13.0) |
| Prolonged thrombocytopenia‡ | 143 (20.3) | 57 (27.3) | 86 (17.4) | 10 (18.5) |
| Duration, median (95% CI), d | 61 (57-74) | 62 (53-81) | 61 (55-78) | NE (36 to NE) |
| Recovery|| | 87 (60.8) | 36 (63.2) | 51 (83.6) | 4 (7.4) |
| Death any time after infusion¶ | 188 (26.7) | 74 (35.4) | 114 (23.1) | 16 (29.6) |
| Death due to recurrence, persistence, or progression of primary disease | 96 (13.7) | 37 (17.7) | 59 (11.9) | 10 (18.5) |
| Nonrelapse mortality# | 90 (12.8) | 35 (16.7) | 55 (11.1) | 6 (11.1) |
| . | All patients (N = 703) . | ≥18 years (n = 209) . | <18 years (n = 494) . | <3 years (n = 54) . |
|---|---|---|---|---|
| CRS∗ | ||||
| All grade | 404 (57.5) | 131 (62.7) | 273 (55.3) | 33 (61.1) |
| Grade ≥3 | 115 (16.4) | 36 (17.2) | 79 (16.0) | 4 (7.4) |
| Median time to onset (range), d | 5 (1-38) | 5 (1-38) | 5 (1-24) | 6 (1-11) |
| Median duration (95% CI), d | 6 (6-7) | 6 (5-8) | 6 (6-7) | 5 (3-7) |
| Therapies | 245 (60.6) | 86 (65.6) | 159 (58.2) | 19 (57.6) |
| Corticosteroids | 62 (15.3) | 26 (19.8) | 36 (13.2) | 3 (9.1) |
| Siltuximab | 21 (5.2) | 7 (5.3) | 14 (5.1) | 2 (6.1) |
| Tocilizumab | 214 (53.0) | 78 (59.5) | 136 (49.8) | 14 (42.4) |
| Resolution | 381 (94.3) | 128 (97.7) | 253 (92.7) | 30 (90.9) |
| Death† | 3 (0.4) | 0 | 3 (0.6) | 0 |
| ICANS∗ | ||||
| All grade | 156 (22.2) | 47 (22.5) | 109 (22.1) | 7 (13.0) |
| Grade ≥3 | 63 (9.0) | 18 (8.6) | 45 (9.1) | 5 (9.3) |
| Median time to onset (range), d | 7 (1-93) | 8 (1-33) | 7 (2-93) | 6 (3-12) |
| Median duration (95% CI), d | 7 (6-8) | 7 (4-9) | 7 (5-8) | 7 (3-8) |
| Therapies | 106 (67.9) | 38 (80.9) | 68 (62.4) | 4 (57.1) |
| Antiepileptics | 53 (34.0) | 18 (38.3) | 35 (32.1) | 3 (42.9) |
| Corticosteroids | 47 (30.1) | 20 (42.6) | 27 (24.8) | 2 (28.6) |
| Siltuximab | 3 (1.9) | 1 (2.1) | 2 (1.8) | 0 |
| Tocilizumab | 24 (15.4) | 10 (21.3) | 14 (12.8) | 1 (14.3) |
| Resolution | 142 (91.0) | 44 (93.6) | 98 (89.9) | 7 (16.3) |
| Death† | 1 (0.1) | 1 (0.5) | 0 | 0 |
| Other outcomes of interest | ||||
| Prolonged neutropenia‡ | 152 (21.6) | 60 (28.7) | 92 (18.6) | 12 (22.2) |
| Duration, median (95% CI), d | 55 (48-60) | 57 (45-61) | 53 (44-60) | 63 (33 to NE) |
| Recovery§ | 102 (67.1) | 40 (66.7) | 62 (67.4) | 7 (13.0) |
| Prolonged thrombocytopenia‡ | 143 (20.3) | 57 (27.3) | 86 (17.4) | 10 (18.5) |
| Duration, median (95% CI), d | 61 (57-74) | 62 (53-81) | 61 (55-78) | NE (36 to NE) |
| Recovery|| | 87 (60.8) | 36 (63.2) | 51 (83.6) | 4 (7.4) |
| Death any time after infusion¶ | 188 (26.7) | 74 (35.4) | 114 (23.1) | 16 (29.6) |
| Death due to recurrence, persistence, or progression of primary disease | 96 (13.7) | 37 (17.7) | 59 (11.9) | 10 (18.5) |
| Nonrelapse mortality# | 90 (12.8) | 35 (16.7) | 55 (11.1) | 6 (11.1) |
Efficacy-evaluable set. Data are presented as n (%).
NE, not estimable.
Onset within 100 days after infusion.
Primary cause of death within 30 days.
Assessments conducted at day 100, month 6, and month 12.
Absolute neutrophil count ≥0.5 × 103/µL achieved and sustained for 3 laboratory values.
Platelet count of ≥20 × 109/L.
Treatment-related mortality was not captured separately.
Causes of nonrelapse mortality are listed in supplemental Table 3.