ArticleCancer medicine2023
Hepatic failure associated with immune checkpoint inhibitors: An analysis of the Food and Drug Administration Adverse Event Reporting System database.
Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics.Clinical pharmacology and therapeutics · 2026Article
- Hepatic and Pancreatobiliary Immune-Related Adverse Events in Patients Receiving Immune Checkpoint Inhibitors: A Multidisciplinary Approach.Biomedicines · 2026Review
- Neoadjuvant chemotherapy combined with antiangiogenic therapy and immune checkpoint inhibitors for the treatment of locally advanced gastric cancer: a real - world retrospective cohort study.Frontiers in immunology · 2025Article
- Hepatobiliary complications of immune checkpoint inhibitors in cancer.Exploration of targeted anti-tumor therapy · 2024Review
- Review
- Fulminant Liver Failure after Treatment with a Checkpoint Inhibitor for Gastric Cancer: A Case Report and Review of the Literature.Journal of clinical medicine · 2023Article
- Hepatic failure associated with immune checkpoint inhibitors: An analysis of the Food and Drug Administration Adverse Event Reporting System database.Cancer medicine · 2023Article
- Evaluation of immune checkpoint inhibitor-associated hepatotoxic adverse events: A pharmacovigilance analysis based on the FAERS database.International journal of immunopathology and pharmacologyArticle
- A Rare Case of Early-Onset Steroid-Refractory Fulminant Hepatitis Following Dual Checkpoint Inhibition in Melanoma Initially Presenting With Hemorrhagic Brain Metastasis.Journal of investigative medicine high impact case reportsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHepatic failure induced by immune checkpoint inhibitors (ICIs) has been reported in only a few case series and case reports.
objectiveWe aimed to explore the association between ICIs and hepatic failure and characterize the clinical features of ICI-associated hepatic failure in the pharmacovigilance database.
methodsData from the first quarter (Q1) of 2015 to the fourth quarter (Q4) of 2021 in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database were retrieved for disproportionality and Bayesian analysis. Reporting odds ratios (ROR) and information component (IC) were used to evaluate correlations between ICIs and hepatic failure.
resultsHepatic failure occurred in 0.19% (18,454/9,647,655) of all cases in the FAERS database, of which 654 cases were associated with ICIs. The overall median time from ICIs initiation to hepatic failure onset was 38 days, 72.3% of the adverse events occurred within the first 3 months, and 68.65% of the cases died after developing hepatic failure. In general, a strong signal was shown between ICIs and hepatic failure (ROR
conclusionsICIs had possible strong signals associated with hepatic failure, and most cases of hepatic failure occurred within the first 3 months and had poor outcomes, which should attract clinical attention.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.