Case Report
Copyright ©The Author(s) 2022.
World J Clin Cases. Mar 16, 2022; 10(8): 2468-2473
Published online Mar 16, 2022. doi: 10.12998/wjcc.v10.i8.2468
Table 2 Search criteria in Vigibase® (characterization of hepatitis or cholestasis)
Adverse drug reactions list for extraction
The minimal set of data needed for extraction
Cholestasis and jaundice (HLT); Hepatic and hepatobiliary disorders NEC (HLT); Hepatic enzymes and function abnormalities (HLT); Hepatobiliary signs and symptoms (HLT); Cholestatic liver injury (PT); Drug-induced liver injury (PT); Hepatitis (PT); Hepatitis acute (PT); Hepatitis toxic (PT); Hepatocellular injury (PT); Hepatotoxicity (PT)Patient age above 18 years old; Patient gender specified in the ICSR
HLT and PT from the MedDRA® hierarchy