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Table 2 Safety assessment results by primary and secondary outcome measures

From: Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab

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
  1. 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;
  2. aYates-corrected χ2 test; btwo-tailed Fisher exact test