Grade 3 or 4 treatment-related AEs occurred in 12/58 (21%) patients; the most common were anemia (4 patients [7%]); fatigue and aspartate aminotransferase increase (each in 2 patients [3%]); and abdominal pain, alanine aminotransferase (ALT) increase, arthralgia, asthenia, autoimmune hepatitis, blood alkaline phosphatase increase, blood creatine phosphokinase increase, dehydration, diarrhea, hypercalcemia, hyperkalemia, hypertension, lipase increase, myasthenia gravis, myositis, and urinary tract infection (each in 1 patient [2%]). This evidence concerns the gene GPT and urinary tract infection.