Table 3.

Summary of efficacy

	Patients (N = 92)
Response	IRC assessment	Investigator assessment
Objective response rate, n (%)	4 (4)	10 (11)
95% CI*	1-11	5-19
Best overall response
CR	1 (1)	2 (2)
PR	3 (3)	8 (9)
SD	35 (38)	39 (42)
Progressive disease	46 (50)	35 (38)
Unable to determine	7 (8)	8 (9)
DOR, median† (95% CI), mo	10.9 (8.3-13.6)	12.1 (1.6-NA)
TTR, median† (IQR), mo	5.0 (2.1-10.4)	5.3 (2.0-7.6)

Data reported as n (%) unless indicated otherwise. Assessments are based on the 2007 International Working Group criteria.

IQR, interquartile range; NA, not available; TTR, time to response.

^*CIs based on the Clopper–Pearson method.

^†Computed using Kaplan-Meier method.