GPT and urinary tract infection: Grade 3/4 treatment-emergent AEs occurring in >1 patient treated with epacadostat doses ≤50 mg BID were AST elevation, colitis (n = 4 each); ALT elevation, fatigue (n = 3 each); and confusional state, hyperglycemia, hyponatremia, hypotension, and urinary tract infection (n = 2 each).