Statistical analysis
ADVERSE EVENT
Based on the results of several studies, the effect size and standard deviation (SD) of the DSN for the originator (pegfilgrastim 3.6 mg) were estimated to be 1.9 days and 1.4 days, respectively. The DSN threshold value was set at 3.0 days by adding 1.0 days, about one‐half of 1.9 days, to 2.0 days, which is the mean DSN for the originator. In terms of efficacy, 20 patients were needed to ensure that the probability of the upper limit of a two‐sided 95% confidence interval (CI) for the mean DSN being less than the threshold is greater than 90%. On the contrary, from the safety viewpoint, 100 patients were required to detect at least one adverse event whose incidence is 3% or higher with a 95% probability. The target sample size of 100 patients was determined by both safety and efficacy evaluations.Efficacy analyses were performed on the full analysis set (FAS), consisting of patients who received at least one dose of MD‐110 with at least one postbaseline ANC. The primary efficacy endpoint, DSN, was analyzed by descriptive statistics and a two‐sided 95% CI of the mean. DSN for cycle 1 withdrawn patients with the last ANC of <500/mmSafety analyses were performed on the safety analysis set (SS), consisting of patients who received at least one dose of MD‐110 with postbaseline safety data. AEs were analyzed by calculating the incidence rate. All statistical analyses were performed using SAS Release 9.4 (SAS Institute Inc., Cary, NC, USA).