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

Table 3 Sensitivity analysis for overall response rate

Analysis Set	Treatment	n/N	(%)	Relative Risk	90% CI
Randomized	BCD-021 (N=212)	71/212	33.49	1.0557	[81.79%; 136.26%]
Randomized	reference bevacizumab (N=145)	46/145	31.72	1.0557	[81.79%; 136.26%]
ITT	BCD-021 (N=205)	71/205	34.63	1.024	[79.6%; 131.73%]
ITT	reference bevacizumab (N=136)	46/136	33.82	1.024	[79.6%; 131.73%]
PP	BCD-021 (N=163)	71/163	43.56	1.0133	[80.2%; 128.04%]
PP	reference bevacizumab (N=107)	46/107	42.99	1.0133	[80.2%; 128.04%]

Note: ITT- intent to treat, PP- per protocol, N = number of subjects in reference bevacizumab Set, n = number of subjects with responses.

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