ArticleDrug safety2021
Immune Checkpoint Inhibitors and Cardiotoxicity: An Analysis of Spontaneous Reports in Eudravigilance.
Article in Drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 2 of them syntheses 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
55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Safety of immune checkpoint inhibitors: A systematic review of disproportionality analysis studies.European journal of clinical pharmacology · 2026Pooled it
- Comparative cardiotoxicity risk of pembrolizumab versus nivolumab in cancer patients undergoing immune checkpoint inhibitor therapy: A meta-analysis.Frontiers in oncology · 2023Pooled it
- The onset of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with the use of decongestant agents: a European pharmacovigilance analysis.Pharmacological reports : PR · 2026Article
- The association between colorectal cancer drugs and heart failure: a real-world pharmacovigilance study of the FAERS database.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- SSRIs-induced liver injury adverse events: a data-based retrospective study and investigation of potential toxicological mechanisms.Frontiers in pharmacology · 2026Article
- Will the introduction of β-lactamase inhibitors alter the adverse event profile of parent penicillins antibiotics? a pharmacovigilance study based on amoxicillin-clavulanate and ampicillin-sulbactam.Frontiers in pharmacology · 2026Article
- Post marketing safety surveillance of atezolizumab based on a retrospective analysis of the FDA adverse events reporting system (FAERS).Scientific reports · 2025Article
- Thromboembolism in patients with melanoma receiving immune checkpoint inhibitors: incidence and risk factors.Immuno-oncology technology · 2025Article
- Pharmacovigilance on Dexamethasone 1 mg/mL + Levofloxacin 5 mg/mL Eye Drops, Solution: A Five-Year Registry.Clinical and translational science · 2025Article
- Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on FAERS database.Scientific reports · 2025Article
- Review
- Safety assessment of apremilast: real-world adverse event analysis from the FAERS database.Archives of dermatological research · 2025Article
- Renal injury in NSAIDs: a real-world analysis based on the FAERS database.International urology and nephrology · 2025Article
- Sodium-glucose cotransporter 2 inhibitors and the cancer patient: from diabetes to cardioprotection and beyond.Basic research in cardiology · 2025Review
- Comparative safety profile of levofloxacin versus moxifloxacin in first-line tuberculosis therapy: a pharmacovigilance study of the FAERS database.Frontiers in pharmacology · 2025Article
- Pharmacovigilance study on the reporting frequency of atrial fibrillation with immune checkpoint inhibitors: insights from FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2025Article
- CardioAI: A Multimodal AI-based System to Support Symptom Monitoring and Risk Prediction of Cancer Treatment-Induced Cardiotoxicity.Proceedings of the SIGCHI conference on human factors in computing systems. CHI Conference · 2025Article
- Drug-associated hearing impairment in children: a disproportionality analysis of the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Atrial Fibrillation and Cancer-Epidemiology, Mechanisms, and Management.Journal of clinical medicine · 2024Review
- Safety of Inclisiran: A Disproportionality Analysis from the EudraVigilance Database.Pharmaceuticals (Basel, Switzerland) · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionImmune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with the development of immune-related adverse drug reactions (ADRs). Among immune-related ADRs, cardiac immune-related ADRs are rare, but also associated with high mortality rates.
objectiveThe objective of this study was to evaluate the occurrence of cardiac ADRs reported with ICIs in the European spontaneous reporting system.
methodsWe retrieved individual case safety reports on ICI-induced cardiac ADRs from the website of suspected ADR ( www.adrreports.eu ) of the European pharmacovigilance database (Eudravigilance). Data were retrieved from the date of marketing authorization of each ICI (ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, and cemiplimab) to 14 March, 2020. The reporting odds ratio and its 95% confidence interval were computed to assess the reporting frequency of cardiac ADRs for each ICI compared to all other ICIs.
resultsA total of 2478 individual case safety reports with at least one ICI as the suspected drug were retrieved from Eudravigilance, of which 249 (10%) reported more than one ICI. The three most reported ICIs were nivolumab (43.2%), pembrolizumab (32.5%), and the association of nivolumab/ipilimumab (9.4%). A total of 3388 cardiac ADRs were identified. Cardiac ADRs were serious (99.4%) and had a fatal outcome (30.1%). The most reported cardiac events were myocarditis, cardiac failure, atrial fibrillation, pericardial effusion, and myocardial infarction. Nivolumab was reported with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs (reporting odds ratio 1.09, 95% confidence interval 1.01-1.18).
conclusionsImmune checkpoint inhibitor-induced cardiac ADRs were serious and had unfavorable outcomes. In our study, nivolumab was the only ICI with a small increased reporting frequency of individual case safety reports with cardiac ADRs compared to all other ICIs. In this regard, further head-to-head studies are needed.
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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.