Statistical analysis
death
REGRESSION, DISEASE PROGRESSION
The analyses are based on intention-to-treat principle. The primary analysis of progression free survival is planned when approximately 90% of patients had the progression. The progression-free survivals between the two group will be compared using a stratified log-rank test at the two-sided significant level of 0.05. The hazard ratio of progression free survival is estimated by stratified Cox regression analysis. The stratification factors are the same used for randomization. The Kaplan–Meier method is used to estimate the median progression free survival. Patients with no documentation of disease progression or death during the trials are censored at date of last contact alive. The other time-to-event endpoints will be analyzed with the same methods as the progression free survival. The proportion of patients with binary endpoint and the corresponding 95% confidence intervals (CIs) for each group will be estimated by using the Clopper-Pearson method and compared between the two groups with the Cochran–Mantel–Haenszel test. In the continuous endpoints, the mean change and the corresponding 95% CI from baseline at each visit will be estimated for each group and compared between the two group with analysis of covariance (or mixed-effects model for repeated measures). No interim analysis will be conducted.