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Clinical Pattern of Tolvaptan-Associated Liver Injury in Trial Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD): An Analysis of Pivotal Clinical Trials
Institution:1. Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, St Louis, Missouri;2. Georgetown University School of Medicine, Washington, DC;3. Duke University Medical Center and Durham Veterans Affairs Health Care System, Durham, North Carolina;4. University of Connecticut Health Center, Farmington, Connecticut;5. Mayo Clinic, Rochester, Minnesota;6. Otsuka Pharmaceutical Development & Commercialization, Inc, Rockville, Maryland
Abstract:
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  • Keywords:Autosomal dominant polycystic kidney disease (ADPKD)  tolvaptan  drug-induced liver injury (DILI)  clinical trial  liver safety  Hy’s Law  alanine aminotransferase (ALT)  aspartate aminotransferase (AST)  hepatic events  drug rechallenge  JYNARQUE
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