AEs in the TE and post-TE periods
| TE period∗ . | ||
|---|---|---|
| TEAEs overview, n (%) . | Liso-cel–treated analysis set (n = 61) . | |
| Any grade . | Grade ≥3 . | |
| Any TEAE | 59 (97) | 48 (79) |
| Any serious TEAE | 20 (33) | 13 (21) |
| Liso-cel related | 48 (79) | 27 (44) |
| Most common any-grade TEAEs in ≥20% | ||
| Any grade | Grade ≥3 | |
| Neutropenia | 31 (51) | 29 (48) |
| Fatigue | 24 (39) | 0 |
| CRS | 23 (38) | 1 (2) |
| Anemia | 19 (31) | 7 (11) |
| Thrombocytopenia | 18 (30) | 13 (21) |
| Nausea | 15 (25) | 1 (2) |
| Leukopenia | 14 (23) | 13 (21) |
| Post-TE period† | ||
| AEs† overview, n (%) | Liso-cel–treated analysis set (n = 57) | |
| Any grade | Grade ≥3 | |
| Any AE | 29 (51) | 10 (18) |
| Any serious AE | 5 (9) | 3 (5) |
| Liso-cel related | 6 (11) | 3 (5) |
| Most common AEs† in ≥3% of patients | ||
| Any grade | Grade ≥3 | |
| Anemia | 5 (9) | 3 (5) |
| Thrombocytopenia | 4 (7) | 3 (5) |
| Lymphopenia | 2 (4) | 2 (4) |
| Neutropenia | 2 (4) | 1 (2) |
| TE period∗ . | ||
|---|---|---|
| TEAEs overview, n (%) . | Liso-cel–treated analysis set (n = 61) . | |
| Any grade . | Grade ≥3 . | |
| Any TEAE | 59 (97) | 48 (79) |
| Any serious TEAE | 20 (33) | 13 (21) |
| Liso-cel related | 48 (79) | 27 (44) |
| Most common any-grade TEAEs in ≥20% | ||
| Any grade | Grade ≥3 | |
| Neutropenia | 31 (51) | 29 (48) |
| Fatigue | 24 (39) | 0 |
| CRS | 23 (38) | 1 (2) |
| Anemia | 19 (31) | 7 (11) |
| Thrombocytopenia | 18 (30) | 13 (21) |
| Nausea | 15 (25) | 1 (2) |
| Leukopenia | 14 (23) | 13 (21) |
| Post-TE period† | ||
| AEs† overview, n (%) | Liso-cel–treated analysis set (n = 57) | |
| Any grade | Grade ≥3 | |
| Any AE | 29 (51) | 10 (18) |
| Any serious AE | 5 (9) | 3 (5) |
| Liso-cel related | 6 (11) | 3 (5) |
| Most common AEs† in ≥3% of patients | ||
| Any grade | Grade ≥3 | |
| Anemia | 5 (9) | 3 (5) |
| Thrombocytopenia | 4 (7) | 3 (5) |
| Lymphopenia | 2 (4) | 2 (4) |
| Neutropenia | 2 (4) | 1 (2) |
AEs were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, except for CRS, which was graded per Lee 2014 criteria.
TE period was defined as ≤90 days after liso-cel administration.
Post-TE period started from 91 days after liso-cel administration, initiation of subsequent anticancer therapy, or liso-cel retreatment before day 91, whichever came first.