Key safety outcomes
| Safety outcome, n (%) | N=116 |
| AE, any grade | 116 (100.0) |
| TRAE, any grade | 94 (81.0) |
| AE, grade ≥3 | 70 (60.3) |
| TRAE, grade ≥3 | 21 (18.1) |
| Serious AE | 58 (50.0) |
| Serious TRAE | 17 (14.7) |
| AE leading to death | 15 (12.9) |
| TRAE leading to death | 0 |
| AE leading to permanent treatment discontinuation | 30 (25.9) |
| TRAE leading to permanent treatment discontinuation | 14 (12.1) |
| irAE,* any grade | 35 (30.2) |
| irAE,* grade ≥3 | 7 (6.0) |
| IRR,† any grade | 34 (29.3) |
| IRR,† grade ≥3 | 1 (0.9) |
*Based on a prespecified list of Medical Dictionary for Regulatory Activities terms followed by comprehensive medical review.
†Composite term, which includes AEs categorized as IRR, anaphylactic reaction, drug hypersensitivity, type I hypersensitivity, or hypersensitivity reaction that occurred on the day of or day after infusion, in addition to signs/symptoms of IRR that occurred on the day of infusion (during or after the infusion) that resolved on the day of onset or next day; includes AEs classified by investigators as related or unrelated to treatment.
AE, adverse event (any causality); irAE, immune-related adverse event; IRR, infusion-related reaction; TRAE, treatment-related adverse event.