Table 2

Incidence of all-grade treatment-related adverse events occurring in ≥5% of patients by dose cohort

Preferred term
n (%)
0.01
mg/kg
(n=2)
0.03
mg/kg
(n=2)
0.1
mg/kg
(n=6)
0.2
mg/kg
(n=6)
0.4
mg/kg
(n=5)
0.8
mg/kg
(n=4)
1.6
mg/kg
(n=3)
2.4
mg/kg
(n=3)
3.6
mg/kg
(n=28)
Total
(N=59)
Any TRAE2 (100)2 (100)5 (83)4 (67)2 (40)3 (75)1 (33)1 (33)19 (68)39 (66)
Fatigue02 (100)3 (50)1 (17)1 (20)1 (25)004 (14)12 (20)
Asthenia001 (17)1 (17)00006 (21)8 (14)
IRR001 (17)1 (17)01 (25)004 (14)7 (12)
Decreased appetite1 (50)01 (17)01 (20)0003 (11)6 (10)
Fever001 (17)1 (17)00003 (11)5 (8)
Dizziness01 (50)1 (17)000001 (4)3 (5)
Headache000001 (25)01 (33)1 (4)3 (5)
Nausea001 (17)000002 (7)3 (5)
Pruritus00000001 (33)2 (7)3 (5)
Myalgia002 (33)000001 (4)3 (5)
  • IRR, infusion-related reaction; TRAE, treatment-related adverse event.