Table 3

Key safety outcomes

Safety outcome, n (%)N=116
AE, any grade116 (100.0)
TRAE, any grade94 (81.0)
AE, grade ≥370 (60.3)
TRAE, grade ≥321 (18.1)
Serious AE58 (50.0)
Serious TRAE17 (14.7)
AE leading to death15 (12.9)
TRAE leading to death0
AE leading to permanent treatment discontinuation30 (25.9)
TRAE leading to permanent treatment discontinuation14 (12.1)
irAE,* any grade35 (30.2)
irAE,* grade ≥37 (6.0)
IRR,† any grade34 (29.3)
IRR,† grade ≥31 (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.