TABLE 3.
AEs of special interest and their management
| Parameter | Liso‐cel‐treated patients (N = 10) |
|---|---|
| Patients with TEAEs, n (%) | |
| CRS (Lee 2014 criteria), 26 | |
| All grades, n (%) | 5 (50) |
| Grade 1 | 3 (30) |
| Grade 2 | 2 (20) |
| Time to onset, median (range), days | 3 (2–9) |
| Time to resolution, median (range), days | 4 (1–5) |
| Grade ≥ 3 CRS n (%) | 0 |
| NEs | |
| All grades, n (%) | 1 (10) |
| Grade 1 | 1 (10) |
| Time to onset, days | 4 |
| Time to resolution, days | 3 |
| Grade ≥ 3, n (%) | 0 |
| Management of CRS and/or NEs, n (%) | |
| Tocilizumab only for CRS management | 2 (20) |
| Corticosteroids only for NEs management | 0 |
| Tocilizumab and corticosteroids for concurrent CRS and NEs | 1 (10) |
| Prolonged cytopenia, a n (%) | 6 (60) |
Abbreviations: AE, adverse event; CRS, cytokine release syndrome; liso‐cel, lisocabtagene maraleucel; NE, neurological event; TEAE, treatment‐emergent adverse event.
a
Based on laboratory assessments of neutropenia, thrombocytopenia, or anemia of grade ≥3 not resolved by study day 29.