Skip to main content

Table 4 Safety endpoints (pooled safety population)

From: Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-021 with reference bevacizumab

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

  1. 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;