Drug-related, treatment-emergent adverse events
occurring in ≥10% of patients at any grade
Adverse event, %
Regorafenib
N=500
Placebo
N=253
All
grades
G-3
G-4
All
grades
G-3
G-4
Hand–foot skin reaction
46.6
16.6
0
7.5
0.4
0
Fatigue
47.4
9.2
0.4
28.1
4.7
0.4
Hypertension
27.8
7.2
0
5.9
0.8
0
Diarrhea
33.8
7.0
0.2
8.3
0.8
0
Rash/desquamation
26.0
5.8
0
4.0
0
0
Anorexia
30.4
3.2
0
15.4
2.8
0
Mucositis, oral
27.2
3.0
0
3.6
0
0
Thrombocytopenia
12.6
2.6
0.2
2.0
0.4
0
Fever
10.4
0.8
0
2.8
0
0
Nausea
14.4
0.4
0
11.1
0
0
Bleeding
11.4
0.4
0
2.8
0
0
Voice changes
29.4
0.2
0
5.5
0
0
Weight loss
13.8
0
0
2.4
0
0
Adverse events
leadi to
permanent Tx
discontinuation
8.2%
1.2%
