Table 5.

Deaths, serious adverse events, and adverse events leading to permanent discontinuation of study drug (safety population)

AEs, n (%)	Everolimus N  =  120
Patients with any AE(s)	89 (74.2)
Death	0 (0.0)
SAE(s)	32 (26.7)
Discontinuation due to AE(s) a	8 (6.7)
AE(s) causing dose adjustment or study drug interruption	36 (30.0)
CTC Grade 3 or 4	28 (23.3)
Leading to hospitalization/prolonged hospitalization	29 (24.2)
Suspected to be drug related	62 (51.7)

AE adverse event, CTC common terminology criteria, SAE serious adverse event

^aIncludes abnormal laboratory values