Table 2.

Febrile neutropenia in cycles 1, 2, 3, and 4 (intent-to-treat population)

Cycle	Placebo			Lipegfilgrastim 6 mg SC			Lipegfilgrastim 6 mg SC vs. placebo
	N	FN	%	N	FN	%	OR	95% CI	P value*
1	125	7	5.6	250	6	2.4	0.390	0.121–1.260	0.1151
2	105	0	0	214	1	0.5	NE	NE	0.9551
3	92	1	1.1	188	1	0.5	0.642	0.234–1.762	0.3883
4	81	2	2.5	171	2	1.2	0.421	0.119–1.489	0.1787

CI confidence interval, FN febrile neutropenia, NE not evaluable, OR odds ratio, SC subcutaneously.

* P values based on a null hypothesis of odds ratio = 1.