|
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)
|
- AE, adverse event; CTC, Common Terminology Criteria; IRRs, infusion-related reactions. aOne-sided CI for serious events. bDue to AE, medication error, or other reason such as bathroom break.
