The reported number of patients wit

The reported number of patients with an iDFS event that occurred within 2 years after randomization was 173; of these, 67 (4.7%) were in the neratinib arm and 106 (7.5%) were in the placebo arm. The 2-year iDFS rate was greater in the neratinib arm than in the placebo arm, 94.2% and 91.9%, respectively. Results from the Applicant’s 5-year exploratory analysis with reconsent data from 74.5% of the ITT patients show that the initial 2-year difference seen in the primary analysis appears to be sustained for up to 5-years. Certain subgroup analyses demonstrate the potential for a difference in magnitude of benefit; however, no subgroups demonstrated a potential detriment, and these analyses were exploratory.