Table 5.

Frequent AEs (≥ 20% in all patients), regardless of study drug relationship—bid dosing schedule

	BEZ235 bid
	400 mg N = 8
PT	All grades n (%)	Grade ¾ n (%)
Total	8 (100.0)	7 (87.5)
Diarrhea	7 (87.5)	1 (12.5)
Nausea	7 (87.5)	0
Decreased appetite	7 (87.5)	1 (12.5)
Thrombocytopenia	5 (62.5)	2 (25.0)
Stomatitis	5 (62.5)	0
Fatigue	5 (62.5)	1 (12.5)
Lymphopenia	4 (50.0)	2 (25.0)
Vomiting	4 (50.0)	0
Alanine aminotransferase increased	4 (50.0)	0
Aspartate aminotransferase increased	4 (50.0)	1 (12.5)
Haemoglobin decreased	4 (50.0)	1 (12.5)
Insomnia	4 (50.0)	0
Dry skin	4 (50.0)	0
Rash	4 (50.0)	0
Hypoalbuminaemia	4 (50.0)	1 (12.5)
Cheilitis	3 (37.5)	0
Dysphagia	3 (37.5)	0
Cancer pain	3 (37.5)	2 (25.0)
Blood creatinine increased	3 (37.5)	0
Malaise	2 (25.0)	1 (12.5)
Pyrexia	2 (25.0)	0
Urinary tract infection	2 (25.0)	0
Blood alkaline phosphatase increased	2 (25.0)	0
Gamma-glutamyltransferase increased	2 (25.0)	0
Hyperkalaemia	2 (25.0)	0
Hyponatraemia	2 (25.0)	1 (12.5)
Anxiety	2 (25.0)	0

AEs are listed in descending order within PT level

AE adverse event, bid twice daily, PT preferred term