AEs of special interest in the TE and post-TE periods (liso-cel–treated analysis set)
| AE, n (%) . | TE period (n = 61) . | Post-TE period (n = 57) . |
|---|---|---|
| CRS∗ | ||
| Any grade | 23 (38) | 0 |
| Grade 1/2 | 22 (36) | 0 |
| Grade 3 | 1 (2) | 0 |
| Grade 4/5 | 0 | 0 |
| NEs† | ||
| Any grade | 19 (31) | 0 |
| Grade 1/2 | 16 (26) | 0 |
| Grade 3 | 3 (5) | 0 |
| Grade 4/5 | 0 | 0 |
| Prolonged cytopenia at day 29‡ | 18 (30) | N/A |
| Grade ≥3 infections | 4 (7) | 1 (2)§ |
| Second primary malignancy | 0 | 2 (4)|| |
| AE, n (%) . | TE period (n = 61) . | Post-TE period (n = 57) . |
|---|---|---|
| CRS∗ | ||
| Any grade | 23 (38) | 0 |
| Grade 1/2 | 22 (36) | 0 |
| Grade 3 | 1 (2) | 0 |
| Grade 4/5 | 0 | 0 |
| NEs† | ||
| Any grade | 19 (31) | 0 |
| Grade 1/2 | 16 (26) | 0 |
| Grade 3 | 3 (5) | 0 |
| Grade 4/5 | 0 | 0 |
| Prolonged cytopenia at day 29‡ | 18 (30) | N/A |
| Grade ≥3 infections | 4 (7) | 1 (2)§ |
| Second primary malignancy | 0 | 2 (4)|| |
N/A, not available.
CRS was graded per Lee 2014 criteria.
NEs were defined as investigator-identified neurological AEs related to liso-cel and were graded per the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Prolonged cytopenia was defined as grade ≥3 laboratory result of decreased hemoglobin, decreased neutrophil count, or decreased platelet count at the day 29 visit.
Bacteremia and sepsis.
Squamous cell carcinoma of skin and malignant external ear neoplasm (n = 1) and myelodysplastic syndrome (n = 1).