ArticleBMC cancer2025
Adverse drug reaction to tremelimumab and durvalumab in hepatocellular carcinoma patients: an analysis of the food and drug administration adverse event reporting system database.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Post-marketing safety of tarlatamab in small cell lung cancer based on FAERS and WHO-VigiAccess with SHAP-based interpretable machine learning analysis of immune-related adverse events.Frontiers in pharmacology · 2026Article
- A real-world drug safety surveillance study from the FAERS database of hepatocellular carcinoma patients receiving durvalumab in combination with tremelimumab.Frontiers in immunology · 2025Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study sought to comprehensively evaluate the safety profile of tremelimumab and durvalumab in patients with hepatocellular carcinoma (HCC) by examining adverse drug reaction (ADR) documented in the Food and Drug Administration's Adverse Event Reporting System (FAERS) database.
methodsData from the FAERS database spanning from the first quarter of 2004 to the first quarter of 2025 were extracted, filtered, and standardized. The Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) method were utilized to analyze the signal strength and identify potential ADRs.
resultsA total of 574 cases and 1,021 ADR reports were identified. Gastrointestinal disorders (15.65%, n = 188), hepatobiliary disorders (12.16%, n = 146), and general disorders and administration site conditions (11.74%, n = 141) emerged as the most frequently reported categories by system organ class (SOC). Death, diarrhea, and malignant neoplasm progression were identified as the three most common preferred terms (PT) based on reporting frequency. Immune-mediated ADRs with elevated ROR and BCPNN values were prevalent across multiple systems, particularly within the gastrointestinal (528.22, 9.03), hepatic (863.82, 9.70), cardiac (365.24, 8.49), endocrine (321.26, 8.31), and dermatological (744.71, 9.51) domains.
conclusionThe study underscored the intricate safety profile of tremelimumab and durvalumab in HCC patients, characterized predominantly by immune-mediated toxicities and significant gastrointestinal and hepatobiliary risks. Utilization of drugs necessitated meticulous patient selection and a multidisciplinary management approach to optimize patient outcomes and mitigate ADRs.
Indexed as
Identifiers
What OpenQuestion 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 OpenQuestion graph.