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| |
400 mg (n = 6)
|
300 mg (n = 18)
|
All patients (N = 24)
|
|---|
| |
All grades
|
G 3/4
|
All grades
|
G 3/4
|
All grades
|
G 3/4
|
|---|
| |
n
|
(%)
|
n
|
(%)
|
n
|
(%)
|
n
|
(%)
|
n
|
(%)
|
n
|
(%)
|
|
Nausea,Vomiting
|
6
|
100
|
0
|
0
|
11
|
61
|
0
|
0
|
19
|
79
|
0
|
0
|
|
Diarrhea
|
6
|
100
|
2
|
33
|
11
|
61
|
0
|
0
|
17
|
71
|
2
|
8
|
|
Mucositis oral
|
6
|
100
|
1
|
17
|
11
|
61
|
0
|
0
|
17
|
71
|
1
|
4
|
|
Liver function tests increased
|
1
|
0
|
1
|
0
|
10
|
56
|
1
|
6
|
11
|
46
|
2
|
8
|
|
Anorexia
|
5
|
83
|
0
|
0
|
3
|
17
|
0
|
0
|
8
|
33
|
0
|
0
|
|
Hyperglycemia
|
1
|
17
|
1
|
17
|
7
|
39
|
1
|
6
|
8
|
33
|
2
|
8
|
|
Dyspepsia
|
2
|
33
|
0
|
0
|
3
|
17
|
0
|
0
|
5
|
21
|
0
|
0
|
|
Stomach or abdominal pain
|
2
|
33
|
0
|
0
|
3
|
17
|
0
|
0
|
5
|
21
|
0
|
0
|
|
Neutropenia
|
1
|
17
|
1
|
17
|
4
|
22
|
1
|
6
|
5
|
21
|
2
|
8
|
|
Anemia
|
1
|
17
|
0
|
0
|
3
|
17
|
2
|
11
|
4
|
17
|
2
|
8
|
|
Fatigue
|
2
|
33
|
0
|
0
|
2
|
11
|
0
|
0
|
4
|
17
|
0
|
0
|
|
Platelet count decreased
|
0
|
0
|
0
|
0
|
4
|
22
|
4
|
22
|
4
|
17
|
4
|
17
|
|
Bloating, Flatulence
|
2
|
33
|
0
|
0
|
2
|
11
|
0
|
0
|
4
|
17
|
0
|
0
|
|
Anal pain
|
3
|
50
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
13
|
0
|
0
|
|
C-peptide increase
|
0
|
0
|
0
|
0
|
3
|
17
|
0
|
0
|
3
|
13
|
0
|
0
|
|
Constipation
|
2
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
0
|
0
|
|
Alkaline phosphatase increased
|
0
|
0
|
0
|
0
|
2
|
11
|
0
|
0
|
2
|
8
|
0
|
0
|
|
Lipase increased
|
0
|
0
|
0
|
0
|
2
|
11
|
1
|
6
|
2
|
8
|
1
|
4
|
|
Weight loss
|
2
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
0
|
0
|
|
Hypertriglyceridemia
|
2
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
0
|
0
|
|
Hoarseness
|
2
|
33
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
8
|
0
|
0
|
|
Colitis
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Gastroenteritis
|
0
|
0
|
0
|
0
|
1
|
6
|
1
|
6
|
1
|
4
|
1
|
4
|
|
Esophagitis
|
0
|
0
|
0
|
0
|
1
|
6
|
1
|
6
|
1
|
4
|
1
|
4
|
|
Erythema multiforme
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Skin infection
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Nail ridging
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Urea increased
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Serum amylase increased
|
0
|
0
|
0
|
0
|
1
|
6
|
1
|
6
|
1
|
4
|
1
|
4
|
|
Dry skin
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Insomnia
|
0
|
0
|
0
|
0
|
1
|
6
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Muscle cramps
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Dizziness
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Dysgeusia
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
|
Alopecia
|
1
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
0
|
0
|
- Treatment associated adverse events are listed according to frequency. Gastrointestinal AEs like vomiting, diarrhea and oral mucositis were most frequent but only in rare cases with higher grades (3/4). The most frequent AE with higher grade was lowering of thrombocyte count
