Table 3.

Summary of efficacy

Patients (N = 92)
ResponseIRC assessmentInvestigator 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) 
Patients (N = 92)
ResponseIRC assessmentInvestigator 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.

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