Table 2.

Patient disposition

	n (%)
Total patients treated	61 (100)
Entered extension studya	8 (13.1)
Discontinued core treatment	53 (86.9)
Adverse event(s)	18 (29.5)
Withdrew consent	15 (24.6)
Disease progression	11 (18.0)
Administrative problemsb	5 (8.2)
Abnormal test procedure result(s)	1 (1.6)
Protocol violation	1 (1.6)
Lost to follow-up	1 (1.6)
Deathc	1 (1.6)

^aEnrolled in the ongoing extension portion of the study at the time of data cutoff

^bOne patient underwent dose interruption for thrombocytopenia, which did not resolve within the time period specified by the protocol; the patient was therefore removed from the study by the sponsor. The other 4 patients were discontinued due to unsatisfactory response (all had stable disease)

^cOnly includes patients for whom death was cited as the primary reason for discontinuation of study treatment