Statistical methods
SECONDARY, SENSITIVITY
Assuming an expected difference in the DSN for efbemalenograstim alfa as compared to placebo of 2.0 days, with a common standard deviation (SD) of 3 days. Patients were randomized in a 2:1 ratio, and the dropout rate for the trial was 10%. Under these assumptions, enrollment of 80 subjects for the efbemalenograstim alfa arm and 40 subjects for the placebo group for cycle 1 would be required.For the primary endpoint analysis, the mean DSN in cycle 1 between placebo and efbemalenograstim alfa was compared using two-sample Every effort was made to minimize the number of missing values for the ANC values. Local laboratory results were collected and were used for the analysis when the central laboratory ANC values were not available. Imputation methods were applied impute missing ANC value. Sensitivity analyses of pattern mixture model and tipping point analysis were used to evaluate the robustness of the primary efficacy results with respect to missing values using multiple imputation methods.If the primary endpoint analysis inferred efbemalenograstim alfa was superior compared to placebo, then a subset of key secondary endpoints was to be tested using a fallback method to retain the type I error rate. The sequence of secondary endpoints for cycle 1 and their allocated The primary analysis population for all efficacy analyses was the Intent-to-Treat (ITT) analysis set, which included all randomized subjects. Safety analyses were performed on all enrolled subjects receiving any study treatment.