Adverse event
|
Famitinib group [cases (%)] (n = 99)
|
Placebo group [cases (%)] (n = 55)
|
---|
Any grade
|
Grade 3–4
|
Any grade
|
Grade 3–4
|
---|
Any eventa
|
92 (92.9)
|
51 (51.5)
|
42 (76.4)
|
20 (36.4)
|
Clinical adverse event
|
Hypertension
|
38 (38.4)
|
11 (11.1)
|
4 (7.3)
|
1 (1.8)
|
Hand-foot syndrome
|
27 (27.3)
|
10 (10.1)
|
1 (1.8)
|
0 (0.0)
|
Diarrhea
|
15 (15.2)
|
1 (1.0)
|
3 (5.5)
|
0 (0.0)
|
Fatigue
|
14 (14.1)
|
3 (3.0)
|
9 (16.4)
|
2 (3.6)
|
Rash
|
8 (8.1)
|
2 (2.0)
|
0 (0.0)
|
0 (0.0)
|
Hypothyroidism
|
7 (7.1)
|
0 (0.0)
|
1 (1.8)
|
0 (0.0)
|
Oral mucositis
|
7 (7.1)
|
0 (0.0)
|
0 (0.0)
|
0 (0.0)
|
Nausea
|
6 (6.1)
|
0 (0.0)
|
4 (7.3)
|
1 (1.8)
|
Decrease appetite
|
6 (6.1)
|
0 (0.0)
|
5 (9.1)
|
0 (0.0)
|
Headache
|
6 (6.1)
|
1 (1.0)
|
2 (3.6)
|
1 (1.8)
|
Vomit
|
5 (5.1)
|
1 (1.0)
|
2 (3.6)
|
1 (1.8)
|
Dizziness
|
5 (5.1)
|
0 (0.0)
|
2 (3.6)
|
0 (0.0)
|
Backache
|
3 (3.0)
|
0 (0.0)
|
3 (5.5)
|
0 (0.0)
|
Abdominal distension
|
2 (2.0)
|
0 (0.0)
|
3 (5.5)
|
0 (0.0)
|
Cough
|
2 (2.0)
|
0 (0.0)
|
5 (9.1)
|
0 (0.0)
|
Laboratory abnormalities
|
Proteinuria
|
42 (42.4)
|
6 (6.1)
|
9 (16.4)
|
0 (0.0)
|
Neutropenia
|
41 (41.4)
|
9 (9.1)
|
1 (1.8)
|
1 (1.8)
|
Leukopenia
|
36 (36.4)
|
3 (3.0)
|
1 (1.8)
|
0 (0.0)
|
Thrombocytopenia
|
31 (31.3)
|
10 (10.1)
|
1 (1.8)
|
1 (1.8)
|
Increased γ-GT
|
20 (20.2)
|
7 (7.1)
|
11 (20.0)
|
7 (12.7)
|
Increased ALT
|
17 (17.2)
|
3 (3.0)
|
8 (14.5)
|
1 (1.8)
|
Increased AST
|
16 (16.2)
|
2 (2.0)
|
7 (12.7)
|
0 (0.0)
|
Increased ALP
|
14 (14.1)
|
0 (0.0)
|
6 (10.9)
|
2 (3.6)
|
Hypercholesterolemia
|
11 (11.1)
|
0 (0.0)
|
2 (3.6)
|
0 (0.0)
|
Hypertriglyceridemia
|
11 (11.1)
|
0 (0.0)
|
2 (3.6)
|
0 (0.0)
|
Anemia
|
7 (7.1)
|
0 (0.0)
|
4 (7.3)
|
1 (1.8)
|
Increase bilirubin
|
5 (5.1)
|
1 (1.0)
|
1 (1.8)
|
0 (0.0)
|
Hyperglycemia
|
1 (1.0)
|
0 (0.0)
|
3 (5.5)
|
1 (1.8)
|
-
γ-GT γ-glutamyltranspeptidase, ALT alanine transaminase, AST aspartate transaminase, ALP alkaline phosphatase
-
aSome patients had experienced several AEs