ArticleBMC cancer2025
Retrospective analysis of pembrolizumab-related adverse reactions and death outcomes based on the FAERS 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
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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.
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Who cites it
2 citing papers in PubMed.
- Squamous Cell Carcinoma of the Skin in a Teenager with Fanconi Anemia: A Challenging Treatment.International journal of molecular sciences · 2026Article
- Immune-Related Adverse Events in Bladder Cancer Patients Treated With Immune Checkpoint Inhibitors: Insights From a FAERS Disproportionality Analysis.Cancer medicine · 2026Article
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Authors and funding
5 authors.
Funding
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Abstract
objectiveThis study aimed to analyze the characteristics of adverse reactions in cancer patients treated with Pembrolizumab based on the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, and to assess the characteristics and risk factors of fatality reports.
methodsThe study data was sourced from the FAERS database, collecting adverse event reports related to Pembrolizumab from 2013 to June 2024. The main analysis variables included gender, age, cancer type, country, reporter type, and adverse reaction outcomes. Descriptive statistics, univariate analysis, and multivariate Logistic regression models were used to assess the relationship between each variable and fatal outcome.
resultsA total of 46,883 adverse reactions were collected, including 5,483 reports with fatal outcomes. The number of events has been increasing since 2013, especially peaking in 2022 and 2023. The United States and Japan had the highest number of adverse reaction reports. The number of serious events reported increased significantly with age, especially in the 51-65 and 66-80 age groups. The age of patients who died was concentrated in the elderly group (≥ 65 years old), and the median treatment duration time of pembrolizumab was 17 days. Analysis showed that gender (OR = 0.75; 95%CI: 0.71-0.80, p < 0.01), age (OR = 0.89; 95%CI: 0.84-0.96, p < 0.01), and ingredients count (OR = 1.92; 95%CI: 1.84-2.01, p < 0.01) were significantly associated with the treatment duration of pembrolizumab.
conclusionThe serious adverse reactions in cancer patients treated with Pembrolizumab are closely related to patient individual characteristics and cancer types. It is necessary to strengthen the monitoring of high-risk groups such as the elderly in clinical treatment to reduce the risk of fatal outcomes.
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