ArticleCancers2021
Thromboembolic Events with Cyclin-Dependent Kinase 4/6 Inhibitors in the FDA Adverse Event Reporting System.
Article in Cancers, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Treatment consequence and adverse events of cyclin-dependent kinase 4/6 inhibitors on patients with hormone receptor-positive, HER2-negative metastatic breast cancer: a systematic review and meta-analysis.Annals of medicine · 2025Pooled it
- Cardiovascular event burden in women with breast cancer treated with CDK4/6 inhibitors: a retrospective matched cohort study.Cardio-oncology (London, England) · 2026Article
- Characterization of skin adverse events associated with cetuximab: real-world insights from the two global pharmacovigilance databases of FAERS and VigiAccess.Frontiers in oncology · 2026Article
- Real-world FAERS safety analysis of Pralsetinib.Scientific reports · 2025Article
- The crosstalk of breast cancer and ischemic heart disease.Cell death discovery · 2025Review
- Characterization of ocular adverse events associated with crizotinib: real-world insights from the two global pharmacovigilance databases of FAERS and VigiBase.Frontiers in oncology · 2025Article
- Toxicity profiles of cyclin-dependent kinase 4/6 inhibitors: safety analysis from clinical trials and the FDA adverse event reporting system.Frontiers in oncology · 2025Article
- Emerging cardiovascular toxicity associated with CDK4/6 inhibitors: real-world insights from the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Proton pump inhibitors use and risk of type 2 diabetes mellitus: correlation analysis, prediction model construction, and key genes identification.Frontiers in pharmacology · 2025Article
- Advancements in breast cancer management: a comprehensive review of ribociclib combined with endocrine therapy.Annals of medicine and surgery (2012) · 2024Review
- Comparative analysis of adverse events associated with CDK4/6 inhibitors based on FDA's adverse event reporting system: a case control pharmacovigilance study.BMC pharmacology & toxicology · 2024Article
- Emerging Toxicities of Antibody-Drug Conjugates for Breast Cancer: Clinical Prioritization of Adverse Events from the FDA Adverse Event Reporting System.Targeted oncology · 2024Article
- Cerebral venous sinus thrombosis in a patient treated with ribociclib for metastatic breast cancer. Case reports and literature review.SAGE open medical case reports · 2024Article
- Association of thrombopoietin-related drugs with thromboembolic events: Mendelian randomization and a real-world study.Therapeutic advances in drug safety · 2024Article
- Adverse event profiles of CDK4/6 inhibitors: data mining and disproportionality analysis of the FDA adverse event reporting system.Therapeutic advances in drug safety · 2024Article
- Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment.Drug safety · 2023Article
- Article
- Liver Injury with Nintedanib: A Pharmacovigilance-Pharmacokinetic Appraisal.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Thrombotic events in patients using cyclin dependent kinase 4/6 inhibitors, analysis of existing ambulatory risk assessment models and the potential influences of tumor specific risk factors.Current problems in cancer · 2022Review
- Psychiatric Adverse Reactions to Anaplastic Lymphoma Kinase Inhibitors in Non-Small-Cell Lung Cancer: Analysis of Spontaneous Reports Submitted to the FDA Adverse Event Reporting System.Targeted oncology · 2022Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
We analyzed thromboembolic events, recognized (AESIs), with cyclin-dependent kinase (CDK)4/6 inhibitors, using the Food and Drug Administration adverse event reporting system.
methodsThromboembolic events were characterized in terms of spectrum [venous and arterial thromboembolism (VTE; ATE)] and clinical features by combining the disproportionality approach [reporting odds ratio (ROR) with 95% confidence interval (CI)] with individual case assessment.
resultsA total of 1722 thromboembolic events were retained. Increased VTE reporting emerged for CDK4/6 inhibitors in the exploratory analyses (
conclusionsAlthough causal association cannot be firmly inferred, oncologists should proactively monitor the occurrence of VTE with CDK4/6 inhibitors. The unexpected distinctive increased ATE reporting with ribociclib deserves urgent clarification though large comparative population-based studies. We support pharmacovigilance for the post-marketing characterization of AESIs, thus promoting real-time safe prescribing in oncology.
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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.