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

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	1.000^a
SAE	8	7.08	13	11.82	0.326^a
Therapy-related SAE	4	3.54	5	4.55	0.746^b
Courses postponed due to AE/SAE	4	3.54	5	4.55	0.746^b
Courses discontinued due to AE/SAE	0	0.00	1	0.91	0.493^b
Lethal outcomes	3	2.65	5	4.55	0.495^b

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

ISSN: 1471-2407