2.2 Definition of hepatic dysfunction Events
We identified hepatic dysfunction events which were in preferred terms
(PTs) using Medical Dictionary for Regulatory Activities terms (V23.0).
Different PTs were identified with the Standardized MedDRA Query (SMQ)
for “livery injury”, “liver related”, “hepatic failure” and
“acute hepatic failure” and the System Organ Class (SOC) for
hepatobiliary disorder, and only reports that met both criteria were
extracted. One case could be reported more than one PTs of the same SMQ,
duplicate records was removed, the number of selected PTs was 48 (see
details in Supplementary Materials Table S2 ).