Subject 001860 was a 55-year-old Caucasian woman who received her first dose of neratinib on 10/9/09. Seven days later, on 10/16/09, she experienced Grade 3 diarrhea and Grade 4 AST/ALT elevations. Bilirubin was also elevated at 27.36 (ULN = 17). Alkaline phosphatase was slightly elevated at 130 (ULN = 120). Abdominal ultrasound revealed fatty infiltration of the liver with mild enlargement of the common bile duct s/p cholecystectomy. She discontinued neratinib and 11 days later her laboratory values had normalized.