Efficacy Analysis of Eribulin in Cancer Studies

The statistical methods have been published with the primary analyses for Studies 206 and 208 (McIntyre et al. 2014 (link); Wilks et al. 2014 (link)). Efficacy analyses were based primarily on the full analysis set (FAS), which included all patients who received ≥1 dose(s) of study treatment. The safety analysis set included all patients who received ≥1 dose(s) of eribulin and had ≥1 postbaseline safety evaluation. All efficacy endpoints were summarized descriptively. Kaplan–Meier method was used to estimate the time to event variables (e.g., PFS). Greenwood method was used to construct 95 % confidence interval (95 % CI) for the median. Exact method was used to construct 95 % CI for rate variables (e.g., ORR). Statistical analyses and summaries were performed using SAS for Windows v. 9.3.