Table 4.

Best overall responses by day 85

Best overall response	Evaluation by RECIST assessment committee and investigatora (N = 38)
CR, n	0
PR, n (%)	2 (5.3)
Stable disease, n (%)	16 (42.1)
PD, n (%)	16 (42.1)
Not evaluated	4 (10.5)
CR or PR, n (%) (response rate)	2 (5.3)
95 % CIb	0.6–17.7 %
90 % CIb	0.9–15.7 %
CR or PR or stable disease, n (%) (disease control rate)	18 (47.4)
95 % CIb	31.0–64.2 %
90 % CIb	33.3–61.8 %

Tumor response (overall response) for each patient was assessed by the investigator and subsequently evaluated by an independent RECIST assessment committee (when the investigator assessed that a patient had been accomplished CR or PR)

CR complete response, PD progressive disease, PR partial response

^aWhen there were evaluation data from both the RECIST committee and investigator, RECIST assessment committee data were adopted

^bBased on exact binomial confidence interval (Clopper–Pearson)