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Data mining and analysis of adverse event signals associated with teprotumumab using the Food and Drug Administration adverse event reporting system database
BackgroundTeprotumumab was approved by the US Food and Drug Administration (FDA) for the treatment of thyroid eye disease in 2020. However, its...
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Data mining and analysis for emicizumab adverse event signals based on the Food and Drug Administration Adverse Event Reporting System database
BackgroundEmicizumab is the latest treatment for patients with hemophilia A. Its safety in real-world data is limited, and regulatory agencies and...
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Thoracic lymphangitis as an immune-related adverse event: a case report
The efficacy of immune checkpoint inhibitors (ICIs) has been widely recognized in several cancers and is now being used in the perioperative setting...
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Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques
IntroductionConcerns have been raised over the quality of drug safety information, particularly data completeness, collected through spontaneous...
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Adverse Event Reporting in Cancer Clinical Trials: Incorporating Patient-Reported Methods. A Systematic Sco** Review
Background and objectiveThe history of clinical trials is fraught with unethical practices. Since 1945, robust frameworks have evolved to standardise...
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Sociodemographic Characteristics of Adverse Event Reporting in the USA: An Ecologic Study
IntroductionThe Food and Drug Administration Adverse Event Reporting System (FAERS) is a vital source of new drug safety information, but whether...
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Statistical methods for exploring spontaneous adverse event reporting databases for drug-host factor interactions
BackgroundDrug toxicity does not affect patients equally; the toxicity may only exert in patients who possess certain attributes of susceptibility to...
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Emerging Toxicities of Antibody-Drug Conjugates for Breast Cancer: Clinical Prioritization of Adverse Events from the FDA Adverse Event Reporting System
BackgroundAntibody-drug conjugates (ADCs) are gaining widespread use in the treatment of breast cancer, although toxicity remains an underexplored...
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An immune-related adverse event of Behcet’s-like syndrome following pembrolizumab treatment
BackgroundIn recent years, the emergence of immunotherapy has renewed therapeutic modality. Different from traditional anti-tumor therapy,...
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Establishment of a medical device adverse event management system for hospitals
BackgroundThe management of medical device adverse event (MDAE) is one of the most important aspects of improving medical quality and safety...
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Exploring the safety profile of tremelimumab: an analysis of the FDA adverse event reporting system
BackgroundDespite the approval of tremelimumab in 2022, there is a lack of pharmacovigilance studies investigating its safety profile in real-world...
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A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry
IntroductionPublished data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are lacking. This...
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Early adverse physiological event detection using commercial wearables: challenges and opportunities
Data from commercial off-the-shelf (COTS) wearables leveraged with machine learning algorithms provide an unprecedented potential for the early...
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Liver injury associated with endothelin receptor antagonists: a pharmacovigilance study based on FDA adverse event reporting system data
BackgroundEndothelin receptor antagonists are commonly used in clinical practice, with concerns about their hepatotoxicity.
AimThis study aimed to...
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Comparison of Adverse Events Occurred During Administration of Dipeptidyl Peptidase-4 Inhibitor in Patients with Diabetes Using FDA Adverse Event Reporting System
Background and ObjectiveVarious dipeptidyl peptidase-4 (DPP-4) inhibitors have been approved for the treatment of diabetes. The frequencies of known...
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Toxicity Spectrum of Anti-GD2 Immunotherapy: A Real-World Study Leveraging the US Food and Drug Administration Adverse Event Reporting System
BackgroundAnti-disialoganglioside (anti-GD2) monoclonal antibodies are effective immunotherapeutic drugs for treating neuroblastoma, yet their...
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Disproportionality Analysis of Abemaciclib in the FDA Adverse Event Reporting System: A Real-World Post-Marketing Pharmacovigilance Assessment
Background and ObjectiveAbemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy in women with hormone receptor-positive,...
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Neuropsychiatric adverse reactions in patients treated with denosumab: two case reports and a review of data from the FDA Adverse Event Reporting System (FAERS)
Denosumab is a human monoclonal antibody indicated for patients with osteoporosis and a high risk of fractures. It targets RANKL, the receptor...
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A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials
Adverse events suffer from poor reporting within randomised controlled trials, despite them being crucial to the evaluation of a treatment. A recent...
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Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System
BackgroundInfigratinib is a fibroblast growth factor receptor (FGFR)-specifc tyrosine kinase inhibitor indicated for the treatment of patients with...