Safety with SOC cilta-cel in 236 patients
| Event∗ . | n (%) or median (range) . |
|---|---|
| CRS | |
| Any grade | 177 (75%) |
| Unknown | 1 |
| Grade ≥3 | 12 (5%) |
| Grade 1 | 115 (49%) |
| Grade 2 | 49 (21%) |
| Grade 3 | 6 (3%) |
| Grade 4 | 3 (1%) |
| Grade 5 | 3 (1%) |
| Grade unknown | 1 |
| Median time to onset from CAR T-cell therapy | 7 days (0-14; IQR, 6-8) |
| ICANS | |
| Any grade | 32 (14%) |
| Unknown | 6 |
| Grade ≥3 | 9 (4%) |
| Grade 1 | 14 (6%) |
| Grade 2 | 8 (3.5%) |
| Grade 3 | 4 (2%) |
| Grade 4 | 4 (2%) |
| Grade 5 | 1 (0.4%) |
| Grade unknown | 1 |
| Median time to onset from CAR T-cell therapy | 9 days (1-51; IQR: 7-12.5) |
| DNT | 24 (10%) |
| Seventh CNP | 11 |
| Diplopia | 4 |
| Parkinsonism | 5 (1 patient with concomitant PRES) |
| PRES | 3 (1 patient with concomitant Parkinsonism) |
| Dysautonomia | 1 |
| Polyneuropathy | 1 |
| Median time to onset from CAR T-cell therapy | 24 d (13-149) |
| IEC-HS | 5 (2%) |
| Infections (any grade; severe) | |
| Any infection | 110 (47%); 49 (46%) |
| Bacterial (any grade; severe) | 41;25 |
| Viral (any grade; severe) | 47;10 |
| Fungal (any grade; severe) | 3;3 |
| Infection with >1 pathogen type | 19;11 |
| Resource utilization | |
| Median duration hospital stay, d | 13 (0-69) |
| Intensive care unit stay, yes | 18 (8%) |
| Tocilizumab use | 141 (61%) |
| Corticosteroid use | 86 (37%) |
| Anakinra use | 27 (12%) |
| Severe hematologic toxicity in first 90 d | |
| Grade ≥3 neutropenia | 163 (80%) |
| Unknown | 33 |
| Grade ≥3 anemia | 61 (37%) |
| Unknown | 71 |
| Grade ≥3 thrombocytopenia | 94 (53%) |
| Unknown | 59 |
| Supportive care for cytopenias | |
| G-CSF | 118 (52%) |
| TPO agonist | 20 (9%) |
| Stem cell boost | 11 (5%) |
| Event∗ . | n (%) or median (range) . |
|---|---|
| CRS | |
| Any grade | 177 (75%) |
| Unknown | 1 |
| Grade ≥3 | 12 (5%) |
| Grade 1 | 115 (49%) |
| Grade 2 | 49 (21%) |
| Grade 3 | 6 (3%) |
| Grade 4 | 3 (1%) |
| Grade 5 | 3 (1%) |
| Grade unknown | 1 |
| Median time to onset from CAR T-cell therapy | 7 days (0-14; IQR, 6-8) |
| ICANS | |
| Any grade | 32 (14%) |
| Unknown | 6 |
| Grade ≥3 | 9 (4%) |
| Grade 1 | 14 (6%) |
| Grade 2 | 8 (3.5%) |
| Grade 3 | 4 (2%) |
| Grade 4 | 4 (2%) |
| Grade 5 | 1 (0.4%) |
| Grade unknown | 1 |
| Median time to onset from CAR T-cell therapy | 9 days (1-51; IQR: 7-12.5) |
| DNT | 24 (10%) |
| Seventh CNP | 11 |
| Diplopia | 4 |
| Parkinsonism | 5 (1 patient with concomitant PRES) |
| PRES | 3 (1 patient with concomitant Parkinsonism) |
| Dysautonomia | 1 |
| Polyneuropathy | 1 |
| Median time to onset from CAR T-cell therapy | 24 d (13-149) |
| IEC-HS | 5 (2%) |
| Infections (any grade; severe) | |
| Any infection | 110 (47%); 49 (46%) |
| Bacterial (any grade; severe) | 41;25 |
| Viral (any grade; severe) | 47;10 |
| Fungal (any grade; severe) | 3;3 |
| Infection with >1 pathogen type | 19;11 |
| Resource utilization | |
| Median duration hospital stay, d | 13 (0-69) |
| Intensive care unit stay, yes | 18 (8%) |
| Tocilizumab use | 141 (61%) |
| Corticosteroid use | 86 (37%) |
| Anakinra use | 27 (12%) |
| Severe hematologic toxicity in first 90 d | |
| Grade ≥3 neutropenia | 163 (80%) |
| Unknown | 33 |
| Grade ≥3 anemia | 61 (37%) |
| Unknown | 71 |
| Grade ≥3 thrombocytopenia | 94 (53%) |
| Unknown | 59 |
| Supportive care for cytopenias | |
| G-CSF | 118 (52%) |
| TPO agonist | 20 (9%) |
| Stem cell boost | 11 (5%) |
G-CSF, granulocyte colony stimulating factor; IEC-HS, immune effector cell–associated hemophagocytic lymphohistiocytosis–like syndrome; IQR, interquartile range; TPO, thrombopoietin.
In addition to missing data described in table, infection severity is missing in 4 patients. The length of hospital stay is missing in 1 patient, intensive care unit admission missing in 10 patients, tocilizumab use missing in 6, steroid use missing in 6, anakinra use missing in 4 patients, G-CSF missing in 7 patients, TPO agonist in 8 patients, and stem cell boost in 14 patients.