Table 4.
Safety endpoints (pooled safety population)
| Deviation | BCD-021 (N = 206) n (%) | Reference bevacizumab (N = 137) n (%) | Total (N=343) n (%) | p-value |
|---|---|---|---|---|
| Any AE (including SAE) | 188 (91.26) | 128 (93.43) | 316 (92.13) | 0.46511 |
| AE Grade 3-5 (including SAE) | 74 (35.92) | 51 (37.23) | 125 (36.44) | 0.80591 |
| SAEs | 28 (13.59) | 15 (10.95) | 43 (12.54) | 0.46901 |
| Therapy-related SAE | 7 (3.40) | 3 (2.19) | 10 (2.92) | 0.74542 |
| Treatments discontinued due to AE/SAE | 4 (1.94) | 2 (1.46) | 6 (1.75) | 1.00002 |
| Deaths | 14 (6.80) | 8 (5.84) | 22 (6.41) | 0.72321 |
Note: 1 - Pearson’s chi-suared test, 2 - Fisher’s exact test; Comparisons and calculation of the statistical significance of the differences between the groups BCD-021 and reference bevacizumab;