Table 2.
Efficacy endpoints assessment results (pooled mITT population)
| Parameter | BCD-021 (N=205) N% (95% CI) | Reference bevacizumab (N=136) N% (95% CI) | p-value |
|---|---|---|---|
| Primary outcome measure | |||
| ORR (confirmed) | 7134.63 (28.46 - 41.38) | 4633.82 (26.41 - 42.12) | 0.87732 |
| Secondary outcome measure | |||
| CR rate (confirmed) | 31.46 (0.5 - 4.21) | 10.74 (0.13 - 4.05) | 1.00001 |
| PR rate (confirmed) | 6833.17 (27.09 - 39.87) | 4533.09 (25.74 - 41.37) | 0.98742 |
| PR rate (unconfirmed) | 52.44 (1.05 - 5.58) | 42.94 (1.15 - 7.32) | 0.74581 |
| Stable disease | 6531.71 (25.72 - 38.36) | 4633.82 (26.41 - 42.12) | 0.68302 |
| Progressive disease | 2713.17 (9.21 - 18.48) | 1511.03 (6.8 - 17.4) | 0.55572 |
Note: ORR – overall response rate; CR – complete response; PR – partial response; N = number of subjects in Analysis Set; n = number of subjects with responses. 1 Fisher's exact test, 2 Pearson's chi-squared test