Statistical considerations
ADVERSE EVENTS, SECONDARY
The primary endpoint, time till progression-free survival, will be analyzed using a non-parametric survival estimate. To this end the method of Turnbull will be used to compute the survival curve [An exploratory analysis of secondary outcomes will be performed. Overall survival will be analyzed using the Kaplan–Meier estimate of survival. For the secondary outcomes, objective response and occurrence of adverse events the proportion of patients with the outcome and confidence intervals using the Wilson method will be calculated [The statistical analysis will be carried out by the Coordination Center for Clinical Trials Düsseldorf (KKSD).