Any-grade AEs occurring in 20% or more of patients and grade 3/4 AE occurring in 5% or more of patients, in the treated population
| Patients, n (%) . | Ide-cel (n = 225) . | SRs (n = 126) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Any AE | 225 (100) | 210 (93) | 124 (98) | 97 (77) |
| Hematologic | 204 (91) | 198 (88) | 92 (73) | 78 (62) |
| Neutropenia | 182 (81) | 177 (79) | 58 (46) | 52 (41) |
| Anemia | 131 (58) | 101 (45) | 47 (37) | 24 (19) |
| Thrombocytopenia | 121 (54) | 95 (42) | 37 (29) | 23 (18) |
| Leukopenia | 65 (29) | 64 (28) | 17 (13) | 13 (10) |
| Lymphopenia | 67 (30) | 65 (29) | 26 (21) | 24 (19) |
| Febrile neutropenia | 16 (7) | 16 (7) | 3 (2) | 2 (2) |
| Nonhematologic | ||||
| Infections and infestations | 125 (56) | 50 (22) | 72 (57) | 25 (20) |
| Pneumonia | 22 (10) | 14 (6) | 10 (8) | 5 (4) |
| Gastrointestinal | 143 (64) | 9 (4) | 66 (52) | 5 (4) |
| Nausea | 55 (24) | 2 (1) | 35 (28) | 0 |
| Diarrhea | 68 (30) | 4 (2) | 31 (25) | 4 (3) |
| General disorders and administration site conditions | 131 (58) | 16 (7) | 81 (64) | 12 (10) |
| Fatigue | 49 (22) | 2 (1) | 44 (35) | 3 (2) |
| Pyrexia | 49 (22) | 2 (1) | 24 (19) | 1 (1) |
| Metabolism and nutrition disorders | 141 (63) | 80 (36) | 50 (40) | 16 (13) |
| Hypokalemia | 68 (30) | 12 (5) | 15 (12) | 1 (1) |
| Hypophosphatemia | 76 (34) | 49 (22) | 10 (8) | 3 (2) |
| Hypomagnesemia | 46 (20) | 2 (1) | 7 (6) | 1 (1) |
| Musculoskeletal and connective tissue disorders | 112 (50) | 14 (6) | 68 (54) | 11 (9) |
| Nervous system disorders | 104 (46) | 14 (6) | 60 (48) | 9 (7) |
| Headache | 41 (18) | 0 | 25 (20) | 1 (1) |
| Respiratory, thoracic, and mediastinal disorders | 93 (41) | 13 (6) | 58 (46) | 7 (6) |
| Dyspnea | 27 (12) | 3 (1) | 28 (22) | 2 (2) |
| Vascular disorders | 72 (32) | 20 (9) | 30 (24) | 6 (5) |
| Hypertension | 33 (15) | 17 (8) | 15 (12) | 5 (4) |
| Immune system disorders | 202 (90) | 14 (6) | 3 (2) | 0 |
| CRS∗ | 197 (88) | 9 (4) | 0 | 0 |
| iiNT† | 34 (15) | 7 (3) | 0 | 0 |
| Serious AEs | 105 (47) | 52 (41) | ||
| Patients, n (%) . | Ide-cel (n = 225) . | SRs (n = 126) . | ||
|---|---|---|---|---|
| Any grade . | Grade 3/4 . | Any grade . | Grade 3/4 . | |
| Any AE | 225 (100) | 210 (93) | 124 (98) | 97 (77) |
| Hematologic | 204 (91) | 198 (88) | 92 (73) | 78 (62) |
| Neutropenia | 182 (81) | 177 (79) | 58 (46) | 52 (41) |
| Anemia | 131 (58) | 101 (45) | 47 (37) | 24 (19) |
| Thrombocytopenia | 121 (54) | 95 (42) | 37 (29) | 23 (18) |
| Leukopenia | 65 (29) | 64 (28) | 17 (13) | 13 (10) |
| Lymphopenia | 67 (30) | 65 (29) | 26 (21) | 24 (19) |
| Febrile neutropenia | 16 (7) | 16 (7) | 3 (2) | 2 (2) |
| Nonhematologic | ||||
| Infections and infestations | 125 (56) | 50 (22) | 72 (57) | 25 (20) |
| Pneumonia | 22 (10) | 14 (6) | 10 (8) | 5 (4) |
| Gastrointestinal | 143 (64) | 9 (4) | 66 (52) | 5 (4) |
| Nausea | 55 (24) | 2 (1) | 35 (28) | 0 |
| Diarrhea | 68 (30) | 4 (2) | 31 (25) | 4 (3) |
| General disorders and administration site conditions | 131 (58) | 16 (7) | 81 (64) | 12 (10) |
| Fatigue | 49 (22) | 2 (1) | 44 (35) | 3 (2) |
| Pyrexia | 49 (22) | 2 (1) | 24 (19) | 1 (1) |
| Metabolism and nutrition disorders | 141 (63) | 80 (36) | 50 (40) | 16 (13) |
| Hypokalemia | 68 (30) | 12 (5) | 15 (12) | 1 (1) |
| Hypophosphatemia | 76 (34) | 49 (22) | 10 (8) | 3 (2) |
| Hypomagnesemia | 46 (20) | 2 (1) | 7 (6) | 1 (1) |
| Musculoskeletal and connective tissue disorders | 112 (50) | 14 (6) | 68 (54) | 11 (9) |
| Nervous system disorders | 104 (46) | 14 (6) | 60 (48) | 9 (7) |
| Headache | 41 (18) | 0 | 25 (20) | 1 (1) |
| Respiratory, thoracic, and mediastinal disorders | 93 (41) | 13 (6) | 58 (46) | 7 (6) |
| Dyspnea | 27 (12) | 3 (1) | 28 (22) | 2 (2) |
| Vascular disorders | 72 (32) | 20 (9) | 30 (24) | 6 (5) |
| Hypertension | 33 (15) | 17 (8) | 15 (12) | 5 (4) |
| Immune system disorders | 202 (90) | 14 (6) | 3 (2) | 0 |
| CRS∗ | 197 (88) | 9 (4) | 0 | 0 |
| iiNT† | 34 (15) | 7 (3) | 0 | 0 |
| Serious AEs | 105 (47) | 52 (41) | ||
In the SRs arm, for the 69 patients who underwent leukapheresis in preparation for planned ide-cel treatment upon documented PD on standard regimen, only AEs before leukapheresis were included. All AEs were assessed from collection of informed consent for a minimum of 6 months after initiation of study treatment; grade ≥3 events continued to be recorded from month 7 until 28 days after PFS discontinuation visit, or 28 days after end-of-treatment visit for patients not continuing in PFS follow-up.
CRS was graded according to modified Lee criteria26; maximum-grade events are reported, patients could have >1 event.
Neurotoxicity includes immune effector cell–associated neurotoxicity syndrome reported by investigator as a neurologic toxicity AE. No parkinsonism or Guillain-Barré syndrome were reported.