Table 2.
Safety assessment results by primary and secondary outcome measures
| Parameter | Group | p-value | |||
|---|---|---|---|---|---|
| Group 1: BCD-022 (n = 113) | Group 2: Reference Trastuzumab (n = 110) | ||||
| n | % | n | % | ||
| Any AE (including SAE) | 106 | 93.81 | 104 | 94.55 | 1.000a |
| SAE | 8 | 7.08 | 13 | 11.82 | 0.326a |
| Therapy-related SAE | 4 | 3.54 | 5 | 4.55 | 0.746b |
| Courses postponed due to AE/SAE | 4 | 3.54 | 5 | 4.55 | 0.746b |
| Courses discontinued due to AE/SAE | 0 | 0.00 | 1 | 0.91 | 0.493b |
| Lethal outcomes | 3 | 2.65 | 5 | 4.55 | 0.495b |
Note: This tabulation does not include the lethal outcome in patient who was randomized but did not receive a single dose of the study drug;
aYates-corrected χ2 test; btwo-tailed Fisher exact test