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| |
400 mg (n = 6)
|
300 mg (n = 18)
|
All patients (N = 24)
|
|---|
| |
Grade 3/4
| |
Grade 3/4
| |
Grade 3/4
| |
|---|
| |
n
|
(%)
|
n
|
(%)
|
n
|
(%)
|
|
Diarrhea
|
2
|
33
|
0
|
0
|
2
|
8
|
|
Mucositis oral
|
1
|
17
|
0
|
0
|
1
|
4
|
|
Neutropenia (Neutrophil count decreased and/or WBC decreased)
|
1
|
17
|
1
|
6
|
2
|
8
|
|
Liver function test: values increased
|
1
|
17
|
1
|
6
|
2
|
8
|
|
Gastroenteritis
|
0
|
0
|
1
|
6
|
1
|
4
|
|
Esophagitis
|
0
|
0
|
1
|
6
|
1
|
4
|
|
Serum amylase increased
|
0
|
0
|
1
|
6
|
1
|
4
|
|
Lipase increased
|
0
|
0
|
1
|
6
|
1
|
4
|
|
Anemia
|
0
|
0
|
2
|
11
|
2
|
8
|
|
Platelet count decreased
|
0
|
0
|
4
|
22
|
4
|
17
|
- Grade 3/4 AEs showed no clear dose correlation but predominance of gastrointestinal AEs in the 400 mg BIS cohort and a higher heamatotoxicity rate in the 300 mg BID cohort
