Table 4.

Adverse events grade 3/4 with dosage correlation

	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