We used the trade names and generic names of drugs included in the National Center for Biotechnology Information(NCBI) to search the FAERS database for ICIs that have been approved for marketing by the FDA, including CTLA-4 (ipilimumab, tremelimumab), PD-1 (nivolumab, cemiplimab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) (S1 Table ).
Adverse events with ICIs related to hepatotoxicity were defined as cases in the FAERS database where the treatment regimen included drugs in the ICIs class and a liver-related adverse reaction in the SOC classification occurred. AEs in the FAERS database are coded according to the preferred terms (PTs) in the Medical Dictionary of Regulatory Activities (MedDRA). According to MedDRA version 23.0, our study includes all liver and hepatobiliary-like diseases (MedDRA code 10019654) and all tumors of the hepatobiliary system (MedDRA code 10019811). In addition, based on the structure and variables of the FAERS database, a single adverse event report of ICIs related to hepatotoxicity was recorded as one case of data, even if more than one adverse event report was reported by the same patient.
Adverse events with ICIs related to hepatotoxicity were defined as cases in the FAERS database where the treatment regimen included drugs in the ICIs class and a liver-related adverse reaction in the SOC classification occurred. AEs in the FAERS database are coded according to the preferred terms (PTs) in the Medical Dictionary of Regulatory Activities (MedDRA). According to MedDRA version 23.0, our study includes all liver and hepatobiliary-like diseases (MedDRA code 10019654) and all tumors of the hepatobiliary system (MedDRA code 10019811). In addition, based on the structure and variables of the FAERS database, a single adverse event report of ICIs related to hepatotoxicity was recorded as one case of data, even if more than one adverse event report was reported by the same patient.
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