Table IV.

Serious treatment-emergent adverse events (AEs), regardless of relationship to study drug.

AE, n (%)	BEZ235 300 mg bid n=20		BEZ235 400 mg bid n=11		All N=31
	All grades	Grade 3/4	All grades	Grade 3/4	All grades	Grade 3/4
Total	8 (40.0)	6 (30.0)	5 (45.5)	3 (27.3)	13 (41.9)	9 (29.0)
Sepsis	2 (10.0)	2 (10.0)	0	0	2 (6.5)	2 (6.5)
Abdominal pain	2 (10.0)	1 (5.0)	0	0	2 (6.5)	1 (3.2)
Cardiac arrest	1 (5.0)	1 (5.0)	0	0	1 (3.2)	1 (3.2)
Constipation	0	0	1 (9.1)	1 (9.1)	1 (3.2)	1 (3.2)
Hepatic pain	0	0	1 (9.1)	1 (9.1)	1 (3.2)	1 (3.2)
Hyponatremia	1 (5.0)	1 (5.0)	0	0	1 (3.2)	1 (3.2)
Infection	1 (5.0)	1 (5.0)	0	0	1 (3.2)	1 (3.2)
Spinal cord compression	0	0	1 (9.1)	1 (9.1)	1 (3.2)	1 (3.2)
Staphylococcal infection	1 (5.0)	1 (5.0)	0	0	1 (3.2)	1 (3.2)
Systolic dysfunction	0	0	1 (9.1)	1 (9.1)	1 (3.2)	1 (3.2)
Ventricular hyperkinesia	0	0	1 (9.1)	1 (9.1)	1 (3.2)	1 (3.2)
Vomiting	1 (5.0)	1 (5.0)	0	0	1 (3.2)	1 (3.2)
Anaemia	1 (5.0)	0	0	0	1 (3.2)	0
Cholestasis	0	0	1 (9.1)	0	1 (3.2)	0
Diarrhoea	0	0	1 (9.1)	0	1 (3.2)	0
Erysipelas	1 (5.0)	0	0	0	1 (3.2)	0
Pyrexia	1 (5.0)	0	0	0	1 (3.2)	0
Spinal column stenosis	1 (5.0)	0	0	0	1 (3.2)	0

A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment at the maximum severity grade. bid, Twice daily.