In all, there were 152 (5.4%) of patients with at least one important protocol deviation, 67 (4.7%) in the neratinib arm and 85 (6.0%) in the placebo arm. The most frequent category of important protocol deviations was eligibility criteria with a total of 137 patients (4.8%); 60 (4.2%) in the neratinib arm and 77 (5.4%) in the placebo arm.