Table 5.

ORR per IMWG 2011 criteria by time points of interest (ITT population)

Time point	ORR (N = 25), n (%)	95% Clopper-Pearson CI
Day 42	20 (80)	0.59-0.93
Day 100*	19 (76)	0.55-0.91
Day 180	16 (64)	0.43-0.82
Day 270	13 (52)	0.31-0.72
Year 1†	11 (44)	0.24-0.65

ORR is defined as the proportion of patients who have a positive response by IMWG 2011 criteria (sCR, CR, VGPR, PR) relative to the total number of patients in the population.

CR, complete response; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.

^*Day 100 responders (n = 19): 1 sCR, 12 VGPR, and 6 PR.

^†Year 1 responders (n = 11): 1 sCR, 1 CR, 8 VGPR, and 1 PR.