Study assessments
pruritus, itching, Cancer
ADVERSE EVENTS, ADVERSE EVENT, CANCER
Study assessment visits were performed at screening; run-in; day 1 (randomization); months 1, 3, and 6; and at a follow-up visit 4 weeks after the end of treatment. Fasting blood samples were obtained at each visit for ALP, total bilirubin, other biochemistry, lipids, bile acid precursor 7α-hydroxy-4-cholesten-3-one (C4), IgM, and hematology assays. Patients recorded a daily pruritus NRS each evening for the previous 24 hours on a scale of 0 (no itching) to 10 (worst imaginable itching) using an e-diary from the run-in visit through the month 6 visit.Safety assessments included physical examinations, vital sign evaluations, and laboratory tests. Treatment-emergent adverse events (TEAEs) were summarized using Medical Dictionary for Regulatory Activities version 21.0 and graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.