ArticleFrontiers in oncology2021
Cutaneous Toxicity Associated With Enfortumab Vedotin: A Real-Word Study Leveraging U.S. Food and Drug Administration Adverse Event Reporting System.
Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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
18 citing papers in PubMed, 30 citations in OpenAlex.
- First-in-Human, Phase I/II Dose Escalation and Expansion Study of Zelenectide Pevedotin in Patients With Advanced Solid Tumors: Results From Monotherapy Dose Escalation.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Type 1 segmental Darier disease unmasked by enfortumab vedotin.JAAD case reports · 2026Article
- Skin toxicity induced by chemotherapy or molecular targeted therapy combined with immune checkpoint inhibitors in Asian patients: A literature review by the Japanese Pharmacist-led Oncodermatology Study Team.International journal of clinical oncology · 2026Review
- Tisotumab vedotin-associated Stevens-Johnson syndrome in a patient with recurrent vulvar cancer: Vulnerability and antibody drug conjugate toxicity considerations.Gynecologic oncology reports · 2026Article
- Cutaneous adverse reactions associated with enfortumab vedotin: a pharmacovigilance study based on the FDA adverse event reporting system.Frontiers in medicine · 2026Article
- Signal mining for non-bleeding adverse event in novel oral anticoagulants: a pharmacovigilance study based on FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Real-world pharmacovigilance of drug-related bone metabolism disorders: integrating FAERS and VigiAccess with a Bradford Hill-based causal plausibility assessment.Frontiers in pharmacology · 2026Article
- One Man's Meat Is Another Man's Poison: High Incidence of Severe Cutaneous Drug Reactions Induced by Enfortumab Vedotin.European urology open science · 2025Article
- Thromboembolic events associated with angiogenesis inhibitors: a real-world study of data from the food and drug administration adverse event reporting system (FAERS) database.Thrombosis journal · 2025Article
- Review
- Balancing effectiveness, toxicity, and individualization: enfortumab vedotin in advanced urothelial cancer.Translational andrology and urology · 2025Article
- Diagnosis and Management of Skin Toxicities in Systemic Treatment of Genitourinary Cancers.Cancers · 2025Review
- Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System.Paediatric drugs · 2024Article
- Post-marketing drug safety surveillance of enfortumab vedotin: an observational pharmacovigilance study based on a real-world database.Frontiers in immunology · 2024Observational
- Severe Cutaneous Toxicity in A 67-Year-Old Patient with Metastatic Urothelial Carcinoma Undergoing Therapy with Enfortumab Vedotin and Pembrolizumab.European journal of case reports in internal medicine · 2024Article
- Severe cutaneous adverse reactions to drugs: A real-world pharmacovigilance study using the FDA Adverse Event Reporting System database.Frontiers in pharmacology · 2023Article
- Do antibody-drug conjugates increase the risk of sepsis in cancer patients? A pharmacovigilance study.Frontiers in pharmacology · 2022Article
- Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy.Cancer journal (Sudbury, Mass.)Review
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionEnfortumab vedotin (EV) has been demonstrated to have a significant response rate in early phase trials and is known for its tolerable side-effect profile. Emerging case reports have raised awareness of cutaneous toxicities, which may be a potentially fatal complication.
objectiveTo assess the potential relevance between EV and cutaneous toxicities reports through data mining of the U.S. Food and Drug Administration (FDA) adverse event reporting system (FAERS).
methodsData from January 1, 2019, to November 4, 2021, in the FAERS database were retrieved. Information component (IC) and reporting odds ratio (ROR) were used to evaluate the association between EV and cutaneous toxicities events.
resultsEV was significantly associated with cutaneous toxicities in the database compared with both all other drugs (ROR 12.90 [10.62-15.66], IC 2.76 [2.52-3.01], middle signal) and platinum-based therapy (ROR 15.11 [12.43-18.37], IC 2.91 [2.66-3.15], middle signal) in the FAERS database. A significant association was detected between EV and all the cutaneous adverse effects (AEs) except erythema, palmar-plantar erythrodysesthesia syndrome, and dermatitis allergic. Both Stevens-Johnson syndrome and toxic epidermal necrolysis occurred 15 times as frequently for EV compared with all other drugs (ROR = 15.20; ROR = 15.52), while Stevens-Johnson syndrome occurred 18 times and toxic epidermal necrolysis occurred 7 times as frequently for EV compared with platinum-based therapy in the database (ROR = 18.74; ROR = 7.80). All groups that limited the gender and age showed a significant association between EV and cutaneous toxicities.
conclusionsA significant signal was detected between EV use and cutaneous toxicities. It is worth noting that Stevens-Johnson syndrome and toxic epidermal necrolysis were significantly associated with EV use.
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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.