Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non-small cell lung cancer receiving myelosuppressive therapy

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Table 4 Incidence of severe and very severe neutropenia in cycles 1, 2, 3, and 4 (ITT population)

Cycle	Placebo			Lipegfilgrastim 6 mg SC			Lipegfilgrastim 6 mg SC vs. placebo
Cycle	N	n	%	N	n	%	Odds ratio	95% CI	P value*
Severe neutropenia (grade 4, ANC <0.5 × 10⁹/L)
1	125	74	59.2	249	80	32.1	0.325	0.206–0.512	<0.0001
2	105	55	52.4	215	36	16.7	0.156	0.086–0.282	<0.0001
3	92	47	51.1	188	26	13.8	0.115	0.057–0.229	<0.0001
4	81	45	55.6	169	25	14.8	0.121	0.062–0.238	<0.0001
All	125	100	80.0	249	103	41.4	0.176	0.105–0.294	<0.0001
Very severe neutropenia (ANC <0.1 × 10⁹/L)
1	125	18	14.4	249	27	10.8	0.700	0.365–1.342	NS
2	105	10	9.5	215	8	3.7	0.298	0.099–0.895	0.031
3	92	9	9.8	188	9	4.8	0.421	0.156–1.138	NS
4	81	11	13.6	169	8	4.7	0.260	0.098–0.687	0.007
All	125	33	26.4	249	40	16.1	0.516	0.300–0.888	0.017

Based on data actually collected.
ANC absolute neutrophil count, CI confidence interval, ITT intent to treat, NS not significant, SC subcutaneously.
*P values based on a null hypothesis of odds ratio = 1.