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

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

Cycle

Duration of severe neutropenia (days)

Placebo

Lipegfilgrastim 6 mg SC

1

N

125

250

Mean ± SD

2.3 ± 2.5

0.6 ± 1.1

Median (range)

2.0 (0–11.0)

0 (0–5.0)

LSM*

−1.661

95% CI*

−2.089 to −1.232

P value*

<0.0001

2

N

122

244

Mean ± SD

2.2 ± 2.6

0.3 ± 0.7

Median (range)

1.0 (0–11.0)

0 (0–4.0)

LSM*

−1.915

95% CI*

−2.317 to −1.512

P value*

<0.0001

3

N

122

245

Mean ± SD

2.0 ± 2.4

0.4 ± 0.9

Median (range)

1.0 (0–11.0)

0 (0–5.0)

LSM*

−1.640

95% CI*

−2.053 to −1.227

P value*

<0.0001

4

N

123

246

Mean ± SD

2.3 ± 2.5

0.5 ± 1.1

Median (range)

1.0 (0–11.0)

0 (0–0.8)

LSM*

−1.844

95% CI*

−2.281 to −1.407

P value*

<0.0001

  1. Includes patients from the ITT population who were withdrawn from the study.
  2. CI confidence interval, ITT intent to treat, LSM least squares mean, SC subcutaneously, SD standard deviation.
  3. *Least squares mean, 95% CI, and P value are for Poisson regression analysis lipegfilgrastim–placebo.