AEs of special interest during the TE period
| . | Liso-cel–treated set (N = 270) . |
|---|---|
| Patients with CRS or NE, n (%) | 127 (47) |
| Patients with CRS,∗ n (%) | |
| Any grade | 113 (42) |
| Grade 1 | 65 (24) |
| Grade 2 | 42 (16) |
| Grade 3 | 4 (1) |
| Grade 4 | 2 (1) |
| Grade 5 | 0 |
| Median time to CRS onset (range), d | 5 (1-14) |
| Median time to resolution of CRS (range), d | 5 (1-17) |
| Treatment with tocilizumab and/or corticosteroids for CRS, n (%) | |
| Tocilizumab only | 27 (10) |
| Corticosteroids only | 5 (2) |
| Both tocilizumab and corticosteroids | 21 (8) |
| Patients with NE,† n (%) | |
| Any grade | 80 (30) |
| Grade 1 | 26 (10) |
| Grade 2 | 27 (10) |
| Grade 3 | 23 (9) |
| Grade 4 | 4 (1) |
| Grade 5 | 0 |
| Median time to NE onset (range), d | 9 (1-66) |
| Median time to resolution of NE (range), d | 11 (1-86) |
| Treatment with tocilizumab and/or corticosteroids for NEs, n (%) | |
| Tocilizumab only | 1 (<1) |
| Corticosteroids only | 36 (13) |
| Both tocilizumab and corticosteroids | 8 (3) |
| Patients with prolonged cytopenia‡ on d 29, n (%) | 101 (37) |
| Patients with grade 3-4 decreased Hb, n (%) | 17 (6) |
| Median time of duration to recovery§ to grade ≤2 in 10 patients (range), d | 21 (3-72) |
| Patients with grade 3-4 decreased platelets, n (%) | 81 (30) |
| Median time of duration to recovery§ to grade ≤2 in 48 patients (range), d | 29.5 (1-328) |
| Patients with grade 3-4 decreased neutrophils, n (%) | 53 (20) |
| Median time of duration to recovery§ to grade ≤2 in 42 patients (range), d | 25.5 (2-336) |
| Infections,‖ n (%) | |
| Any grade | 111 (41) |
| Grade ≥3 | 33 (12) |
| . | Liso-cel–treated set (N = 270) . |
|---|---|
| Patients with CRS or NE, n (%) | 127 (47) |
| Patients with CRS,∗ n (%) | |
| Any grade | 113 (42) |
| Grade 1 | 65 (24) |
| Grade 2 | 42 (16) |
| Grade 3 | 4 (1) |
| Grade 4 | 2 (1) |
| Grade 5 | 0 |
| Median time to CRS onset (range), d | 5 (1-14) |
| Median time to resolution of CRS (range), d | 5 (1-17) |
| Treatment with tocilizumab and/or corticosteroids for CRS, n (%) | |
| Tocilizumab only | 27 (10) |
| Corticosteroids only | 5 (2) |
| Both tocilizumab and corticosteroids | 21 (8) |
| Patients with NE,† n (%) | |
| Any grade | 80 (30) |
| Grade 1 | 26 (10) |
| Grade 2 | 27 (10) |
| Grade 3 | 23 (9) |
| Grade 4 | 4 (1) |
| Grade 5 | 0 |
| Median time to NE onset (range), d | 9 (1-66) |
| Median time to resolution of NE (range), d | 11 (1-86) |
| Treatment with tocilizumab and/or corticosteroids for NEs, n (%) | |
| Tocilizumab only | 1 (<1) |
| Corticosteroids only | 36 (13) |
| Both tocilizumab and corticosteroids | 8 (3) |
| Patients with prolonged cytopenia‡ on d 29, n (%) | 101 (37) |
| Patients with grade 3-4 decreased Hb, n (%) | 17 (6) |
| Median time of duration to recovery§ to grade ≤2 in 10 patients (range), d | 21 (3-72) |
| Patients with grade 3-4 decreased platelets, n (%) | 81 (30) |
| Median time of duration to recovery§ to grade ≤2 in 48 patients (range), d | 29.5 (1-328) |
| Patients with grade 3-4 decreased neutrophils, n (%) | 53 (20) |
| Median time of duration to recovery§ to grade ≤2 in 42 patients (range), d | 25.5 (2-336) |
| Infections,‖ n (%) | |
| Any grade | 111 (41) |
| Grade ≥3 | 33 (12) |
The TE period started any time from initiation of liso-cel administration through and including 90 days after liso-cel infusion. Any AE occurring after the initiation of another anticancer therapy or liso-cel retreatment were not considered as a TEAE.
CRS was graded per Lee 2014 criteria.21
NEs were defined as investigator-identified neurological AEs related to liso-cel and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03.
Prolonged cytopenia is defined as any grade ≥3 laboratory result of decreased Hb, decreased neutrophil count, or decreased platelet count on the day 29 visit. The protocol-defined window for the day 29 visit was 29 ± 2 days after liso-cel infusion. If multiple test results were available in the window, the maximum grade was selected.
The duration of grade 3 to 4 decreased hematology values was calculated as the date of the first grade ≤2 laboratory result after the day 29 visit‒day 29 visit date. Grade ≤2 laboratory results taken within 7 days after red blood cell or platelet transfusion were excluded. Recovery data are presented for patients who had hematology laboratory results after day 29.
Includes all events in the infections and infestations System Organ Class.