ArticlePloS one2025
Real-world safety of Tepotinib: Insights from the Food and Drug Administration Adverse Event Reporting System.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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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
3 citing papers in PubMed.
- Management of Adverse Events Associated with MET TKIs in Patients with Advanced NSCLC: A Podcast Discussion.Targeted oncology · 2026Article
- Management of brain metastases in older adults with non-small cell lung cancer.Frontiers in oncology · 2026Review
- Real-world safety assessment of MET-targeted therapies: a pharmacovigilance analysis using the FAERS database.Drugs in context · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectsTepotinib is widely utilized for treating non-small cell lung cancer (NSCLC) patients with MET exon 14 (METex14) skipping mutations. The purpose of this study is to evaluate the safety characteristics of Tepotinib in the actual environment by analyzing data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database.
methodsThis study analyzed adverse event (AE) reports related to Tepotinib from FAERS database spanning Q1 2021 to Q4 2024. Four disproportionality analysis methods were employed: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS), and Bayesian Confidence Propagation Neural Network (BCPNN). A descriptive analysis and a subgroup analysis of the time to onset (TTO) of AEs was conducted, and the Weibull distribution was used to predict temporal variations in AEs.
resultA total of 521 AE reports involving 1,385 AEs were included in this study. Of these, 69.50% were from the elderly population. The analysis confirmed several known AEs such as death, peripheral edema, diarrhea, and blood creatinine increased while also identifying previously unreported signals, including deafness and taste disorder. For females, special attention ought to be directed toward alopecia, deafness and abdominal pain upper. For males, the onset of interstitial lung disease, pruritus and constipation requires observation. The median time to onset (TTO) of AEs was 39 days, with 43.88% of AEs occurring in the first month of treatment initiation. Additionally, the individuals aged 75 years and over the experience AEs relatively early.
conclusionThis study conducted a comprehensive evaluation of the real-world safety of Tepotinib. The study validates clinical assertions about Tepotinib's safety profile and identifies its novel signals, and also emphasized early monitoring of treatment. Our findings will better guide the clinical practice of Tepotinib and provide a basis for larger prospective studies in the future.
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