Statistical considerations
We are planning a randomized study to test the null hypothesis, that the mPFS in the control (Gem) and experimental arm (GemNab in 80% dose) is equal, opposed to the alternative hypothesis of being nonequal. The study will include 1 control per experimental subject. If the true mPFS in the control and experimental arm is 3 [PFS and OS will be estimated by Kaplan–Meier methods and compared with log-rank test. Patients who are alive will be censored at the last known time the patient is alive. PFS and OS will be summarized by mPFS and mOS along with the hazard ratios (HRs) and including 95% confidence interval (CI).Patient demographics, baseline characteristics and AEs will be described using descriptive statistics. Continuous variables will be summarized with medians and ranges. Categorical variables will be summarized with frequencies and percentages (including 95% CI).