The applicant implemented a reconse

The applicant implemented a reconsent process to acquire extended follow-up data from 2- years through 5-years post-randomization. Per the applicant, recurrent disease and deaths were ascertained from subjects’ medical records upon reconsent. The final update submitted April 2017 showed that 2117 (74.5%) of the 2840 primary analysis patients had been reconsented, consisting of 1028 patients on the neratinib arm and 1089 patients on the placebo arm. There appear to be no differences in baseline characteristics between the reconsented population and the full ITT population or between arms among the reconsented patients.