TRAEs observed in ≥5% of patients
| TRAE, n (%) | By dose groups (N=133) | By severity (N=133) | ||||
| 3 mg/kg (n=6) | 10 mg/kg (n=3) | 15 mg/kg (n=124) | All grades | Grade 1/2 | Grade ≥3 | |
| IRRs | 2 (33.3) | 1 (33.3) | 69 (55.6) | 72 (54.1) | 63 (47.4) | 9 (6.8) |
| Fatigue | 2 (33.3) | 1 (33.3) | 34 (27.4) | 37 (27.8) | 34 (25.6) | 3 (2.3) |
| Rash | 1 (16.7) | 1 (33.3) | 13 (10.5) | 15 (11.3) | 13 (9.8) | 2 (1.5) |
| Nausea | 0 | 0 | 13 (10.5) | 13 (9.8) | 13 (9.8) | 0 |
| Fever | 0 | 1 (33.3) | 11 (8.9) | 12 (9.0) | 12 (9.0) | 0 |
| Lipase increased | 0 | 0 | 11 (8.9) | 11 (8.3) | 3 (2.3) | 8 (6.0) |
| Arthralgia | 1 (16.7) | 0 | 9 (7.3) | 10 (7.5) | 10 (7.5) | 0 |
| Diarrhea | 0 | 0 | 9 (7.3) | 9 (6.8) | 8 (6.0) | 1 (0.8) |
| Decreased appetite | 0 | 0 | 9 (7.3) | 9 (6.8) | 7 (5.3) | 2 (1.5) |
| Hypothyroidism | 0 | 0 | 8 (6.5) | 8 (6.0) | 8 (6.0) | 0 |
| Pneumonitis | 1 (16.7) | 0 | 7 (5.6) | 8 (6.0) | 5 (3.8) | 3 (2.3) |
| Anemia | 0 | 0 | 7 (5.6) | 7 (5.3) | 6 (4.5) | 1 (0.8) |
| Pruritus | 0 | 0 | 7 (5.6) | 7 (5.3) | 7 (5.3) | 0 |
| Lymphocyte count decreased | 0 | 0 | 7 (5.6) | 7 (5.3) | 1 (0.8) | 6 (4.5) |
| Chills | 1 (16.7) | 0 | 6 (4.8) | 7 (5.3) | 7 (5.3) | 0 |
| Total patients with ≥1 event | 5 (83.3) | 3 (100) | 108 (87.1) | 116 (87.2) | 78 (58.6) | 38 (28.6) |
IRR, infusion-related reaction; TRAE, treatment-related adverse event.