GPT and acute kidney injury: Grade 3–4 TEAEs reported in ≥ 5% of patients in the monotherapy cohort were ascites (12%), hyperglycemia (7%), acute kidney injury, anemia, hyponatremia, and hypotension (each 5%), and in the combination therapy cohort were alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, and pulmonary embolism (each 8%).