Events | Infusion 1 (N = 351) n (%)(95% CI)a | Infusion 2 (N = 337) n (%)(95% CI)a | Infusion 3 (N = 289) n (%)(95% CI)a | Infusion 4 (N = 278) n (%)(95% CI)a |
---|---|---|---|---|
Serious IRRs | 0 (0) (- to 0.8) | 0 (0) (- to 0.9) | 0 (0) (- to 1.0) | 0 (0) (- to 1.1) |
IRRs and other AEs | 62 (17.7) (13.8 to 22.1) | 24 (7.1) (4.6 to 10.4) | 22 (7.6) (4.8 to 11.3) | 5 (1.8) (0.6 to 4.1) |
Serious AEs | 0 (0) (- to 0.8) | 0 (0) (- to 0.9) | 0 (0) (- to 1.0) | 0 (0) (- to 1.1) |
CTC grade 3/4 AEs | 2 (0.6) (0.1 to 2.0) | 2 (0.6) (0.1 to 2.0) | 0 (0) (0.1 to 2.1) | 0 (0) (0.0 to 1.3) |
Infusion stopped/slowed/interruptedb | 43 (12.3) (9.0 to 16.1) | 13 (3.9) (2.1 to 6.5) | 19 (6.6) (4.0 to 10.1) | 3 (1.1) (0.2 to 3.1) |