Table 3.
TRAEs (any grade in ≥5% of patients or grade 3/4 in all patients) and IRRs
| Type of event, n (%) | N=153 | |
| Any grade | Grade 3/4* | |
| Any TRAE† | 83 (54.2) | 10 (6.5) |
| Fatigue | 19 (12.4) | 1 (0.7) |
| Fever | 14 (9.2) | 0 |
| Pruritus | 12 (7.8) | 0 |
| Chills | 11 (7.2) | 0 |
| Diarrhea | 10 (6.5) | 0 |
| Asthenia | 6 (3.9) | 1 (0.7) |
| Vomiting | 6 (3.9) | 1 (0.7) |
| Hepatocellular injury | 4 (2.6) | 2 (1.3) |
| Lipase increased | 2 (1.3) | 1 (0.7) |
| Psoriasis | 2 (1.3) | 1 (0.7) |
| Hypophosphatemia | 1 (0.7) | 1 (0.7) |
| Neutrophil count decreased | 1 (0.7) | 1 (0.7) |
| Hyperbilirubinemia | 1 (0.7) | 1 (0.7) |
| IRR‡ | 23 (15.0) | 0 |
*One grade 4 TRAE occurred (hypophosphatemia, n=1); there were no grade 5 TRAEs.
†The incidence of treatment-related IRR based on the single Medical Dictionary for Regulatory Activities preferred term is not listed.
‡Composite term, which includes AEs categorized as IRR, drug hypersensitivity, or hypersensitivity reaction that occurred on the day of infusion or day after infusion, in addition to signs and symptoms of IRR that occurred on the same day of infusion and resolved within 2 days (including AEs classified by investigators as related or unrelated to treatment).
AE, adverse event; IRR, infusion-related reaction; TRAE, treatment-related adverse event.