A phase I study of a dual PI3-kinase/mTOR inhibitor BEZ235 in adult patients with relapsed or refractory acute leukemia

Table 3 Treatment emergent adverse events

	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

ISSN: 2050-6511