Table 1. Summary and Analysis of DSN in Cycle 1.
Treatment groupa | Mean DSN | Noninferiority metb |
---|---|---|
Pegfilgrastimc | 0.25 (0.21-0.29) | NA |
Plinabulinc | 0.77 (0.68-0.86) | NA |
Mean difference between treatment armsd | 0.52 (0.40-0.65) | Met |
Abbreviations: DSN, duration of severe neutropenia; NA, not applicable.
The pegfilgrastim group received docetaxel, 75 mg/m2, plus pegfilgrastim, 6 mg; the plinabulin group received docetaxel, 75 mg/m2, plus plinabulin, 40 mg.
Defined as an upper confidence limit of less than 0.65.
Using 2-sided 95% CI with group sequential adjustment.
Using 2-sided 98.52% CI with group sequential adjustment.