A real-world study of ublituximab based on the WHO-VigiAccess and U.S. food and drug administration’s adverse event reporting system databases [PDF]
ObjectiveThe study bridge statistical pharmacovigilance signals to clinically actionable insights by systematically characterizing adverse event (AE) patterns associated with ublituximab and identifying previously unrecognized risks.
Jiagnang Cao, Qinguo Shen, Yan Zou
doaj +4 more sources
Adverse event profile of five anti head and neck squamous cell carcinoma drugs: a descriptive analysis from WHO-VigiAccess [PDF]
BackgroundHead and neck squamous cell carcinoma (HNSCC) remains a significant global health concern, with treatment outcomes for advanced or metastatic stages being suboptimal despite the availability of various targeted therapies and immunotherapies ...
Weimin Gao +3 more
doaj +4 more sources
Post-marketing safety of tarlatamab in small cell lung cancer based on FAERS and WHO-VigiAccess with SHAP-based interpretable machine learning analysis of immune-related adverse events [PDF]
BackgroundTarlatamab is a DLL3-targeted bispecific T-cell engager approved for previously treated extensive-stage small cell lung cancer (ES-SCLC).
Yingyong Ou +7 more
doaj +3 more sources
Comparative analysis of adverse drug reaction reports for leukotriene receptor antagonists mainly indicated for allergic rhinitis and asthma: a WHO VigiAccess study [PDF]
BackgroundLeukotriene receptor antagonists (LTRAs), including montelukast, pranlukast, and zafirlukast, are generally well tolerated and widely used for asthma and allergic rhinitis, but they may cause adverse drug reactions (ADRs).
Youlin Dong, Zhigang Xia, Weimin Gao
doaj +2 more sources
Profiles and influencing factors of pulmonary fibrosis associated with biologic and conventional disease-modifying antirheumatic drugs for autoimmune diseases: a disproportionality study based on FAERS and VigiAccess [PDF]
BackgroundPulmonary fibrosis is a severe and potentially fatal adverse event, and its association with disease-modifying antirheumatic drugs (DMARDs) has raised long-standing concerns. However, systematic investigations on this topic are lacking.
Xinyue Zhang +7 more
doaj +2 more sources
Antiangiogenic therapy plays a critical role in cancer treatment. This study analyzed vascular and lymphatic adverse events linked to four FDA‐approved agents—aflibercept, bevacizumab, olaratumab, and ramucirumab—using WHO‐VigiAccess data. Disproportionality analysis (ROR and PRR) identified drug‐specific risks, focusing on hypertension, hemorrhage ...
Yue Zu, Lingling Dai, Peng Meng
wiley +3 more sources
A real-world study of adverse drug reactions of two isocitrate dehydrogenase inhibitor based on the US FDA adverse event reporting system and VigiAccess databases [PDF]
Background and objectivesIsocitrate dehydrogenase (IDH) inhibitor drugs (Enasidenib, Ivosidenib) restore normal metabolism and epigenetic regulation in cells, offering a precision-targeted therapeutic option for acute myeloid leukemia (AML) patients with
Mengmeng Peng +11 more
doaj +2 more sources
Pharmacovigilance evaluation of somatrogon-associated adverse events in real-world databases [PDF]
Background: Somatrogon, a long-acting recombinant human growth hormone, is used in children with growth hormone deficiency. While clinical trials have shown its safety, real-world post-marketing data are limited, and uncommon or delayed adverse events ...
Mengyuan Cai +5 more
doaj +2 more sources
Profiles of neuropsychiatric toxicity associated with different endocrine therapies for breast cancer: a global pharmacovigilance study based on FAERS and VigiAccess [PDF]
PurposeBreast cancer is the most common malignancy in women. Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer patients rely on endocrine therapy as their fundamental systemic treatment strategy.
Guoqiang Li +6 more
doaj +2 more sources
Safety profile of ticagrelor: an analysis based on literature and database review [PDF]
Objective Ticagrelor, a reversible P2Y12 receptor antagonist, is widely used in acute coronary syndromes (ACS) for its superior efficacy over clopidogrel.
Renzhu Liu +3 more
doaj +2 more sources

