ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2022
Immune checkpoint inhibitors and potential risk of thromboembolic events: Analysis of the WHO global database of individual case safety reports.
Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed.
- Hematological toxicities and thrombosis risk associated with immune checkpoint inhibitors: a pharmacovigilance study from 2014 to 2024.Cancer immunology, immunotherapy : CII · 2026Article
- Immune-Related Adverse Events Associated with Immune Checkpoint Inhibitors: A Scoping Review.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Post marketing safety surveillance of atezolizumab based on a retrospective analysis of the FDA adverse events reporting system (FAERS).Scientific reports · 2025Article
- Immunotherapy-associated hemostatic abnormalities: bleeding and thrombotic complications.Annals of hematology · 2025Review
- An Exploratory Research to Evaluate the 30 Most Common Pulmonary Embolism Drugs in the Food and Drug Administration Adverse Event Reporting System.The clinical respiratory journal · 2025Article
- Exploring the Emerging Association Between Immune Checkpoint Inhibitors and Thrombosis.Journal of clinical medicine · 2025Review
- Influence of the Immune Checkpoint Inhibitors on the Hemostatic Potential of Blood Plasma.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2025Article
- Article
- New dimensions of PD-1/PD-L1 inhibitor combination therapy in cancer treatment: current advances and future perspectives.Frontiers in immunology · 2025Review
- The role of the PD-1/PD-L1 immune checkpoint pathway in myocardial infarction: a review from pathophysiological mechanisms to therapeutic strategies.Frontiers in cardiovascular medicine · 2025Review
- Targeted anti-cancer agents and risk of venous thromboembolism.Haematologica · 2024Review
- Immune checkpoint inhibitor-associated thrombosis in patients with bladder and kidney cancer: a study of the Spanish Society of Medical Oncology (SEOM) thrombosis and cancer group.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023Article
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4 authors.
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Abstract
Introduction: Thromboembolic events with the use of immune checkpoint inhibitors (ICIs) in patients with cancer have been reported in few studies. However, the detailed profile of these cases remains mostly uncertain. Method: A descriptive analysis of Thromboembolic events associated with ICIs retrieved from the VigiBase, between 1967 to November 2020. We extracted the data using the terms of 'pulmonary embolism' OR 'deep vein thrombosis' OR 'acute coronary syndrome' OR 'myocardial infarction' OR 'ischemic stroke' (preferred term (PT) (MedDRA). Results: We included 161 cases from 26 countries in our descriptive analysis. Patients' ages were reported in 141 (87.6%) cases, with a median of 68 years (interquartile range 61-74), and 63.4% of the patients were male. Indications for ICIs were reported in 151 (93.8%) cases, as follows: lung cancer (n = 85, 52.8%), renal cell carcinoma (n = 24, 14.9%), melanoma (n = 20, 12.4%), urethral carcinoma (n = 12, 7.45%), breast cancer (n = 4, 2.48%), adenocarcinoma of the gastroesophageal junction (n = 3, 1.9%), gastric cancer (n = 2, 1.24%), and skin cancer (n = 1, 0.62%). Nivolumab was reported as a suspected drug in 76 cases (47%), pembrolizumab in 46 cases (28.5%), atezolizumab in 21 cases (13%), durvalumab in 14 cases (8.6%), and avelumab in four cases (2.4%).The time to onset of thromboembolic events was reported in 127 (78.8%) cases. Most of these patients (n = 109, 85.8%) reported thromboembolic events within the first six months. The causality assessment of included cases showed that 50.3% of reported thromboembolic events were possibly related to the suspected reported medication, 13.7% were probably related, 13% were unlikely to be related, and 23% were not assessable due to insufficient information. Conclusion: This study demonstrates a possible association between the use of ICIs and thromboembolic events. Further epidemiological studies are needed to assess this association and to elucidate the underlying mechanism.
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