Subject 001683 was a 54-year-old Caucasian woman who received her first dose of neratinib on 8/5/10. Fourteen days later, she experienced more than 20 episodes of diarrhea associated with abdominal pain, diaphoresis, blurry vision, and a brief syncopal episode while at work. She was admitted to the hospital with hypotension (80/40). Labs were significant for Grade 4 transaminase elevations (ALT was 1376 and AST was 1757), which led to permanent discontinuation of neratinib. Bilirubin remained within normal limits. She was treated with IV hydration. The transaminase elevations were considered recovered/resolved on