TEAEs (liso-cel–treated set)
n (%) . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . | |||
---|---|---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Any TEAE | 57 (100) | 42 (74) | 25 (100) | 19 (76) | 82 (100) | 61 (74) |
Any SAE | 33 (58) | — | 15 (60) | — | 48 (59) | — |
TEAEs occurring in ≥10% of patients | ||||||
Neutropenia | 37 (65) | 31 (54) | 18 (72) | 18 (72) | 55 (67) | 49 (60) |
Leukopenia | 24 (42) | 22 (39) | 12 (48) | 11 (44) | 36 (44) | 33 (40) |
CRS | 21 (37) | 0 | 12 (48) | 0 | 33 (40) | 0 |
Thrombocytopenia | 20 (35) | 14 (25) | 9 (36) | 5 (20) | 29 (35) | 19 (23) |
Anemia | 17 (30) | 13 (23) | 10 (40) | 8 (32) | 27 (33) | 21 (26) |
Fatigue | 20 (35) | 2 (4) | 5 (20) | 0 | 25 (30) | 2 (2) |
Headache | 15 (26) | 0 | 8 (32) | 0 | 23 (28) | 0 |
Nausea | 12 (21) | 0 | 9 (36) | 0 | 21 (26) | 0 |
Constipation | 15 (26) | 0 | 4 (16) | 0 | 19 (24) | 0 |
Decreased appetite | 14 (25) | 4 (7) | 5 (20) | 0 | 19 (24) | 4 (5) |
Diarrhea | 14 (25) | 2 (4) | 5 (20) | 1 (4) | 19 (24) | 3 (4) |
Lymphopenia | 11 (19) | 10 (18) | 6 (24) | 5 (20) | 17 (21) | 15 (18) |
Arthralgia | 12 (21) | 0 | 3 (12) | 0 | 15 (18) | 0 |
Pyrexia | 8 (14) | 0 | 7 (28) | 0 | 15 (18) | 0 |
Dizziness | 8 (14) | 0 | 5 (20) | 1 (4) | 13 (16) | 1 (1) |
Back pain | 8 (14) | 0 | 4 (16) | 0 | 12 (15) | 0 |
Hypokalemia | 8 (14) | 2 (4) | 3 (12) | 1 (4) | 11 (13) | 3 (4) |
Tremor | 8 (14) | 2 (4) | 3 (12) | 0 | 11 (13) | 2 (2) |
Hypotension | 9 (16) | 5 (9) | 1 (4) | 0 | 10 (12) | 5 (6) |
Peripheral edema | 8 (14) | 1 (2) | 2 (8) | 0 | 10 (12) | 1 (1) |
Oropharyngeal pain | 7 (12) | 0 | 3 (12) | 0 | 10 (12) | 0 |
Asthenia | 7 (12) | 0 | 2 (8) | 0 | 9 (11) | 0 |
Cough | 5 (9) | 0 | 4 (16) | 0 | 9 (11) | 0 |
Pruritus | 6 (11) | 0 | 3 (12) | 0 | 9 (11) | 0 |
n (%) . | Outpatients (n = 57) . | Inpatients (n = 25) . | Total (N = 82) . | |||
---|---|---|---|---|---|---|
Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | Any grade . | Grade ≥3 . | |
Any TEAE | 57 (100) | 42 (74) | 25 (100) | 19 (76) | 82 (100) | 61 (74) |
Any SAE | 33 (58) | — | 15 (60) | — | 48 (59) | — |
TEAEs occurring in ≥10% of patients | ||||||
Neutropenia | 37 (65) | 31 (54) | 18 (72) | 18 (72) | 55 (67) | 49 (60) |
Leukopenia | 24 (42) | 22 (39) | 12 (48) | 11 (44) | 36 (44) | 33 (40) |
CRS | 21 (37) | 0 | 12 (48) | 0 | 33 (40) | 0 |
Thrombocytopenia | 20 (35) | 14 (25) | 9 (36) | 5 (20) | 29 (35) | 19 (23) |
Anemia | 17 (30) | 13 (23) | 10 (40) | 8 (32) | 27 (33) | 21 (26) |
Fatigue | 20 (35) | 2 (4) | 5 (20) | 0 | 25 (30) | 2 (2) |
Headache | 15 (26) | 0 | 8 (32) | 0 | 23 (28) | 0 |
Nausea | 12 (21) | 0 | 9 (36) | 0 | 21 (26) | 0 |
Constipation | 15 (26) | 0 | 4 (16) | 0 | 19 (24) | 0 |
Decreased appetite | 14 (25) | 4 (7) | 5 (20) | 0 | 19 (24) | 4 (5) |
Diarrhea | 14 (25) | 2 (4) | 5 (20) | 1 (4) | 19 (24) | 3 (4) |
Lymphopenia | 11 (19) | 10 (18) | 6 (24) | 5 (20) | 17 (21) | 15 (18) |
Arthralgia | 12 (21) | 0 | 3 (12) | 0 | 15 (18) | 0 |
Pyrexia | 8 (14) | 0 | 7 (28) | 0 | 15 (18) | 0 |
Dizziness | 8 (14) | 0 | 5 (20) | 1 (4) | 13 (16) | 1 (1) |
Back pain | 8 (14) | 0 | 4 (16) | 0 | 12 (15) | 0 |
Hypokalemia | 8 (14) | 2 (4) | 3 (12) | 1 (4) | 11 (13) | 3 (4) |
Tremor | 8 (14) | 2 (4) | 3 (12) | 0 | 11 (13) | 2 (2) |
Hypotension | 9 (16) | 5 (9) | 1 (4) | 0 | 10 (12) | 5 (6) |
Peripheral edema | 8 (14) | 1 (2) | 2 (8) | 0 | 10 (12) | 1 (1) |
Oropharyngeal pain | 7 (12) | 0 | 3 (12) | 0 | 10 (12) | 0 |
Asthenia | 7 (12) | 0 | 2 (8) | 0 | 9 (11) | 0 |
Cough | 5 (9) | 0 | 4 (16) | 0 | 9 (11) | 0 |
Pruritus | 6 (11) | 0 | 3 (12) | 0 | 9 (11) | 0 |
—, not available or not reported; SAE, serious AE.