Other Grade 3 TRAEs (abdominal pain, diarrhea, upper GI hemorrhage, gastric dysfunction, abnormal hepatic function, gastroenteritis, infection, increased ALT, increased blood pressure, abnormal coagulation test, hypokalemia, hypoproteinemia, nephrotic syndrome, and pelvi-ureteric obstruction) each occurred in a single patient (2.3%). This evidence concerns the gene GPT and infection.