Table 1.

Reporting Odds Ratios for Association Between Hepatic Disorders and Use of Remdesivir for Coronavirus Disease 2019 in Vigibase^a

Exposures	Casesb	Non-casesc	ROR (95% CI)
Other drugs prescribed for COVID-19d	524	2010	1 (reference)
Remdesivir	130	257	1.94 (1.54–2.45)

CI, confidence interval; COVID-19, coronavirus disease 2019; ROR, reporting odds ratio.

^aWe used the case non-case method, which is similar to case-control studies but adapted for pharmacovigilance studies. We used reporting odds ratios (ROR) and their 95% confidence interval (95% CI) to calculate disproportionality. ROR is a ratio similar in concept to the odds ratio in case-control studies and corresponds to the exposure odds among reported cases of hepatic disorders over the exposure odds among reported non-case.

^bCases were individual case safety reports containing any terms including the terminology “Hepatobiliary disorders” in the System Organ Class (SOC) view found in MedDRA dictionary https://www.meddra.org/.

^cNon-cases were individual case safety reports containing all other adverse events reported linked with the respective drug.

^dHydroxychloroquine, tocilizumab, and lopinavir/ritonavir prescribed for COVID-19 patients.