Table 3.
Best overall response in Japanese subpopulation (response assessment population)
| Nivolumab (N = 129) | Placebo (N = 60) | |
|---|---|---|
| Best overall response, n (%) | ||
| CR | 0 | 0 |
| PR | 18 (14.0) | 0 |
| SD | 40 (31.0) | 14 (23.3) |
| PD | 61 (47.3) | 40 (66.7) |
| NE | 10 (7.8) | 6 (10.0) |
| ORR | ||
| ORR (CR + PR) | 18 (14.0) | 0 |
| (95% CI)a | (8.5, 21.2) | (0.0, 6.0) |
| p valueb | 0.0023* | |
| DCR | ||
| DCR (CR + PR + SD) | 58 (45.0) | 14 (23.3) |
| (95% CI)a | (36.2–54.0) | (13.4–36.0) |
| p valueb | 0.0037* | |
Best overall response was determined solely by imaging assessment according to the RECIST Guideline Version 1.1
CI Confidence interval, CR complete response, DCR disease control rate, ECOG Eastern Cooperative Oncology group, NE, not evaluable, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease
*p < 0.05
aExact 95% CI was calculated using Clopper–Pearson method
bThe calculation of p value was conducted using Cochran–Mantel–Haenszel test adjusted by the following three factors (interactive web response system): (1) location (Japan versus Korea versus Taiwan); (2) ECOG performance status score at baseline (0 versus 1); (3) number of organs with metastases (< 2 vs ≥ 2)