Subject 05781 was a 65-year-old Caucasian woman who received her first dose of neratinib on 3/24/11. No prior medical history was reported and no concomitant medications were reported within 30 days of the onset of diarrhea. The patient had experienced multiple episodes of Grade 3 diarrhea during her course of treatment, and on 6/30/11, approximately 3 months after starting treatment with neratinib, she experienced an episode of non-serious Grade 4 diarrhea. This event was recorded as having resolved the same day. The Grade 4 diarrhea did not lead to hospitalization or temporary discontinuation of neratinib.