Treatment-emergent AEs, n (%)
|
100 mg
|
150 mg
|
200 mg
|
300 mg
|
400 mg
|
500 mg
|
600 mg
|
All patients
|
---|
n = 3
|
n = 6
|
n = 9
|
n = 6
|
n = 6
|
n = 7
|
n = 6
|
n = 43
|
---|
Grade 1/2a
|
Grade 3/4a
|
---|
Any AE
|
3 (100.0)
|
6 (100.0)
|
9 (100.0)
|
6 (100.0)
|
6 (100.0)
|
7 (100.0)
|
6 (100.0)
|
8 (18.6)
|
35 (81.4)
|
Diarrhea
|
2 (66.7)
|
2 (33.3)
|
5 (55.6)
|
3 (50.0)
|
6 (100.0)
|
7 (100.0)
|
6 (100.0)
|
28 (65.1)
|
3 (7.0)
|
Nausea
|
0
|
1 (16.7)
|
2 (22.2)
|
3 (50.0)
|
4 (66.7)
|
5 (71.4)
|
4 (66.7)
|
19 (44.2)
|
0
|
Vomiting
|
0
|
1 (16.7)
|
4 (44.4)
|
2 (33.3)
|
3 (50.0)
|
3 (42.9)
|
3 (50.0)
|
16 (37.2)
|
0
|
Fatigue
|
1 (33.3)
|
1 (16.7)
|
3 (33.3)
|
2 (33.3)
|
2 (33.3)
|
3 (42.9)
|
1 (16.7)
|
9 (20.9)
|
4 (9.3)
|
Edema peripheral
|
2 (66.7)
|
2 (33.3)
|
1 (11.1)
|
0
|
2 (33.3)
|
2 (28.6)
|
3 (50.0)
|
10 (23.3)
|
2 (4.7)
|
Pyrexia
|
1 (33.3)
|
2 (33.3)
|
2 (22.2)
|
1 (16.7)
|
2 (33.3)
|
2 (28.6)
|
2 (33.3)
|
9 (20.9)
|
3 (7.0)
|
Anemia
|
0
|
1 (16.7)
|
1 (11.1)
|
1 (16.7)
|
2 (33.3)
|
2 (28.6)
|
3 (50.0)
|
3 (7.0)
|
7 (16.3)
|
Constipation
|
2 (66.7)
|
2 (33.3)
|
2 (22.2)
|
1 (16.7)
|
2 (33.3)
|
1 (14.3)
|
1 (16.7)
|
11 (25.6)
|
0
|
Abdominal distension
|
0
|
0
|
2 (22.2)
|
1 (16.7)
|
3 (50.0)
|
1 (14.3)
|
2 (33.3)
|
9 (20.9)
|
0
|
Dyspnea
|
2 (66.7)
|
1 (16.7)
|
0
|
0
|
2 (33.3)
|
1 (14.3)
|
3 (50.0)
|
9 (20.9)
|
0
|
Asthenia
|
2 (66.7)
|
2 (33.3)
|
1 (11.1)
|
0
|
0
|
1 (14.3)
|
2 (33.3)
|
6 (14.0)
|
2 (4.7)
|
Decreased appetite
|
2 (66.7)
|
2 (33.3)
|
0
|
0
|
3 (50.0)
|
0
|
1 (16.7)
|
8 (18.6)
|
0
|
Epistaxis
|
2 (66.7)
|
1 (16.7)
|
1 (11.1)
|
2 (33.3)
|
1 (16.7)
|
0
|
1 (16.7)
|
7 (16.3)
|
1 (2.3)
|
Thrombocytopenia
|
1 (33.3)
|
2 (33.3)
|
0
|
1 (16.7)
|
2 (33.3)
|
1 (14.3)
|
1 (16.7)
|
2 (4.7)
|
6 (14.0)
|
Abdominal pain
|
1 (33.3)
|
1 (16.7)
|
1 (11.1)
|
1 (16.7)
|
2 (33.3)
|
0
|
1 (16.7)
|
6 (14.0)
|
1 (2.3)
|
Back pain
|
1 (33.3)
|
2 (33.3)
|
0
|
1 (16.7)
|
2 (33.3)
|
1 (14.3)
|
0
|
7 (16.3)
|
0
|
Insomnia
|
1 (33.3)
|
1 (16.7)
|
2 (22.2)
|
1 (16.7)
|
1 (16.7)
|
1 (14.3)
|
0
|
7 (16.3)
|
0
|
Hyperuricemia
|
1 (33.3)
|
1 (16.7)
|
0
|
0
|
0
|
1 (14.3)
|
3 (50.0)
|
5 (11.6)
|
1 (2.3)
|
Cardiac murmur
|
1 (33.3)
|
0
|
1 (11.1)
|
0
|
1 (16.7)
|
1 (14.3)
|
2 (33.3)
|
6 (14.0)
|
0
|
Dizziness
|
0
|
0
|
2 (22.2)
|
1 (16.7)
|
1 (16.7)
|
1 (14.3)
|
1 (16.7)
|
6 (14.0)
|
0
|
Night sweats
|
1 (33.3)
|
0
|
1 (11.1)
|
0
|
2 (33.3)
|
1 (14.3)
|
1 (16.7)
|
6 (14.0)
|
0
|
Neutropenia
|
1 (33.3)
|
2 (33.3)
|
0
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
2 (4.7)
|
3 (7.0)
|
Chills
|
0
|
2 (33.3)
|
0
|
0
|
1 (16.7)
|
1 (14.3)
|
1 (16.7)
|
5 (11.6)
|
0
|
Cough
|
1 (33.3)
|
1 (16.7)
|
1 (11.1)
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
5 (11.6)
|
0
|
Dehydration
|
0
|
1 (16.7)
|
0
|
0
|
2 (33.3)
|
1 (14.3)
|
1 (16.7)
|
5 (11.6)
|
0
|
Hyperbilirubinemia
|
1 (33.3)
|
1 (16.7)
|
1 (11.1)
|
1 (16.7)
|
1 (16.7)
|
0
|
0
|
5 (11.6)
|
0
|
Pain in extremity
|
3 (100.0)
|
0
|
0
|
1 (16.7)
|
0
|
0
|
1 (16.7)
|
5 (11.6)
|
0
|
Petechiae
|
2 (66.7)
|
2 (33.3)
|
0
|
0
|
0
|
1 (14.3)
|
0
|
5 (11.6)
|
0
|
Skin lesion
|
0
|
4 (66.7)
|
1 (11.1)
|
0
|
0
|
0
|
0
|
5 (11.6)
|
0
|
Upper respiratory tract infection
|
0
|
2 (33.3)
|
2 (22.2)
|
1 (16.7)
|
0
|
0
|
0
|
5 (11.6)
|
0
|
-
aWorst grade during treatment