Evaluation of drug-induced serious hepatotoxicity (eDISH) : application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery.
(2011) Drug Safety — Vol. 34, n° 3, p. 243-252 (2011)
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- Abstract
- The most specific indicator of a drug-induced liver injury signal in a clinical trial database is believed to be the occurrence of subjects experiencing drug-associated elevations in both serum ALT and serum total bilirubin (TB) without a significant elevation in serum alkaline phosphatase (ALP). eDISH (evaluation of Drug-Induced Serious Hepatotoxicity) is a recently described tool that organizes liver laboratory data by graphically displaying peak serum ALT and TB levels for each subject, and can also provide direct links to the pertinent clinical and laboratory data for each subject.
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Watkins, P. B., Desai, M., Berkowitz, S. D., Peters, G., Horsmans, Y., Larrey, D., & Maddrey, W. (2011). Evaluation of drug-induced serious hepatotoxicity (eDISH) : application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery. Drug Safety, 34(3), 243-252. https://doi.org/10.2165/11586600-000000000-00000 (Original work published 2011)