Table 3.
TEAEs (safety set)
| TEAEs∗ | Liso-cel (n = 92) |
SOC (n = 91) |
||
|---|---|---|---|---|
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Patients experiencing any TEAE, n (%) | 92 (100) | 85 (92) | 90 (99) | 81 (89) |
| Patients experiencing any serious TEAE, n (%) | 44 (48) | —† | 45 (49) | —† |
| Deaths due to TEAEs, n (%) | 2 (2) | 2 (2) | ||
| Most common TEAEs (occurring in ≥15% of patients in either arm), n (%) | ||||
| Neutropenia | 76 (83) | 75 (82) | 50 (55) | 47 (52) |
| Anemia | 62 (67) | 48 (52) | 62 (68) | 51 (56) |
| Thrombocytopenia | 55 (60) | 46 (50) | 66 (73) | 62 (68) |
| Nausea | 49 (53) | 3 (3) | 53 (58) | 4 (4) |
| CRS | 45 (49) | 1 (1) | 0 | 0 |
| Headache | 40 (43) | 4 (4) | 21 (23) | 1 (1) |
| Fatigue | 37 (40) | 0 | 37 (41) | 2 (2) |
| Constipation | 30 (33) | 2 (2) | 24 (26) | 0 |
| Pyrexia | 28 (30) | 0 | 23 (25) | 0 |
| Lymphopenia | 25 (27) | 24 (26) | 11 (12) | 9 (10) |
| Diarrhea | 23 (25) | 0 | 39 (43) | 3 (3) |
| Dizziness | 22 (24) | 0 | 13 (14) | 0 |
| Decreased appetite | 21 (23) | 1 (1) | 32 (35) | 4 (4) |
| Hypokalemia | 21 (23) | 4 (4) | 22 (24) | 4 (4) |
| Hypotension | 19 (21) | 3 (3) | 6 (7) | 0 |
| Insomnia | 19 (21) | 0 | 10 (11) | 0 |
| Vomiting | 18 (20) | 1 (1) | 27 (30) | 2 (2) |
| Leukopenia | 17 (18) | 15 (16) | 13 (14) | 11 (12) |
| Febrile neutropenia | 15 (16) | 11 (12) | 24 (26) | 21 (23) |
| Peripheral edema | 15 (16) | 1 (1) | 17 (19) | 0 |
| Hypomagnesemia | 15 (16) | 0 | 21 (23) | 1 (1) |
| Back pain | 14 (15) | 1 (1) | 16 (18) | 2 (2) |
∗
TEAEs were defined as AEs occurring or worsening within 90 days after liso-cel infusion (liso-cel arm or crossover patients), the last dose of chemotherapy (SOC arm), or the start of new antineoplastic therapy, whichever occurred first, and treatment-related AEs occurring at any time thereafter.
†
Not applicable; serious TEAE can be of any grade.