Information within the CSR, Applica

Information within the CSR, Applicant’s narrative summaries, and the CRFs were used to analyze Serious Adverse Events. SAEs of any grade up to 28-days after the last dose of study drug occurred in 7.3% of patients receiving neratinib and 6.0% of patients receiving placebo. No SAE occurred in ≥ 2% of patients. The most frequent treatment-related SAE was diarrhea with 22 patients on the neratinib arm and 1 patient on the placebo arm. All SAEs in the neratinib arm were reversible after discontinuation of study drug except one patient with herpes zoster opthalmicus and one patient with left sided paresis in the setting of glioblastoma.Diarrhea and hepatotoxicity will be discussed further below.