Table 2.
TEAEs reported at all dose levels
| Any grade* | Grade ≥3† | |||
|---|---|---|---|---|
| Total (n = 23) |
Total (n = 23) |
Dose level 1 (n = 9) |
Dose level 2 (n = 14) |
|
| Patients with any TEAE | 23 (100) | 22 (96) | 8 (89) | 14 (100) |
| Anemia | 19 (83) | 17 (74) | 6 (67) | 11 (79) |
| Cytokine release syndrome | 17 (74) | 2 (9) | 0 | 2 (14) |
| Thrombocytopenia | 17 (74) | 16 (70) | 4 (44) | 12 (86) |
| Neutropenia/Neutrophil count decrease | 16 (70) | 16 (70) | 5 (56) | 11 (79) |
| Leukopenia | 11 (48) | 10 (43) | 4 (44) | 6 (43) |
| Pyrexia | 10 (43) | 0 | 0 | 0 |
| Hypokalemia | 9 (39) | 0 | 0 | 0 |
| Diarrhea | 8 (35) | 0 | 0 | 0 |
| Hypophosphatemia | 8 (35) | 5 (22) | 0 | 5 (36) |
| Nausea | 8 (35) | 0 | 0 | 0 |
| Chills | 7 (30) | 0 | 0 | 0 |
| Headache | 7 (30) | 0 | 0 | 0 |
| Tremor | 7 (30) | 0 | 0 | 0 |
| Acute kidney injury | 6 (26) | 1 (4) | 1 (11) | 0 |
| Decreased appetite | 6 (26) | 0 | 0 | 0 |
| Febrile neutropenia | 6 (26) | 6 (26) | 0 | 6 (43) |
| Hypomagnesemia | 6 (26) | 0 | 0 | 0 |
| Hyponatremia | 6 (26) | 0 | 0 | 0 |
| Lymphopenia | 6 (26) | 6 (26) | 2 (22) | 4 (29) |
| Confusional state | 5 (22) | 2 (9) | 0 | 2 (14) |
| Encephalopathy | 5 (22) | 4 (17) | 1 (11) | 3 (21) |
| Hypogammaglobulinemia | 5 (22) | 0 | 0 | 0 |
| Insomnia | 5 (22) | 0 | 0 | 0 |
Data are expressed as n (%).
*
Table shows TEAEs in ≥20% of patients and all corresponding grade ≥3 TEAEs. A TEAE was any AE reported within 90 d of liso-cel administration. Any AE that occurred after initiation of another anticancer treatment was not considered a TEAE.
†
Listing of any grade in >10% of patients and all grade ≥3 TEAEs are shown in supplemental Tables 5 and 6.