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Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis
PharmaceuticalsBackground: Adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult rheumatoid arthritis (RA), and subsequently approved for pediatric treatment of various autoimmune diseases in children of different ages. Due to genetic differences between children and adults in terms of physiology and immunity, there is
Qilin Zhang, Sainan Shu, Zhang Qilin
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Disproportionate Samples in Hierarchical Bayes CBC Analysis
2007Empirical surveys frequently make use of conjoint data records, where respondents can be split up into segments of different size. A lack of knowledge how to handle such random samples when using Hierarchical Bayes-regression gave cause to a more detailed observation of the preciseness of estimation results.
Sebastian Fuchs, Manfred Schwaiger
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Disproportionality Analysis and Causal Inference in Drug Safety
Pharmaceutical MedicineDisproportionality analysis is a method of safety signal detection based on quantitative analysis of spontaneous reports of adverse events. Disproportionality findings are often presented in medical publications as real-world evidence on drug safety.
Emil Scosyrev +4 more
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Detection of signals of abuse and dependence applying disproportionality analysis
European Journal of Clinical Pharmacology, 2014Prescription drug abuse and dependence is a widespread phenomenon in many countries. The use of disproportionality measures in drug abuse surveillance is rarely performed.The aim of this study is to determine the occurrence of signals of abuse and dependence for different psychoactive drugs in real-life settings.Disproportionality analysis was realised
V, Pauly +6 more
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Ocular disorders associated with PCSK9 inhibitors: A pharmacovigilance disproportionality analysis
British Journal of Clinical Pharmacology, 2022AimsTo identify and characterize ocular adverse events (oAEs) that are significantly associated with proprotein convertase subtilisin‐like/kexin type 9 (PCSK9) inhibitors using the US Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsWe conducted a disproportionality analysis of PCSK9 inhibitors in the FAERS (01/2004–12/2021 ...
Xiaofang Zhao, Jiangfan Wu, Shenyin Zhu
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Safety of antipsychotic drugs: A systematic review of disproportionality analysis studies
Behavioural Brain Research, 2021Antipsychotic drugs are commonly prescribed, mainly for the treatment of schizophrenia and other psychotic disorders. Disproportionality analysis of pharmacovigilance data from national and international databases have been recently utilized to investigate the side-effect profiles of antipsychotics and have provided unique insights of their safety ...
Dainora Cepaityte +2 more
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Drug-induced hyperacusis: a disproportionality analysis of the FAERS database
Expert Opinion on Drug SafetyHyperacusis is a non-negligible clinical condition, but reports related to drug-induced hyperacusis are rare. The aim of this study was to investigate the risk of drug-induced hyperacusis and to identify the top drugs that can cause hyperacusis through the FAERS database.We used the search term 'hyperacusis' to query all reports of hyperacusis in the ...
HuaJie, Lin +3 more
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The safety profile of azithromycin in pediatrics: a pharmacovigilance disproportionality analysis
Expert Opinion on Drug SafetyTo mine and analyze adverse drug events (ADEs) signals of azithromycin use in children in the real world to inform the safety assessment of azithromycin use in children.ADE reports from the FDA Adverse Event Reporting System (FAERS) involving children (0-17 years) with azithromycin as the primary suspected drug from 2004 to early 2024 were extracted ...
Yanfei, Ren, Bin, Wang, Hua, Yang
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Adverse Reaction Signaling and Disproportionality Analysis: An Update
Drug Information Journal, 2012There is an increased focus on signal detection, signal management, and the use of use of large collections of adverse event databases to meet the evolving regulatory mandates. The basic elements of signaling require an understanding of the different signaling methods, data mining approaches, and the strengths and limitations of disproportionality ...
Gerald Faich, Jonathan Morris
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Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices
Drug SafetySpontaneous reporting systems (SRS) provide valuable data for detecting unidentified adverse events not observed in clinical trials and for conducting safety assessments that accurately reflect real-world clinical practice. With the increasing number of publications using the SRS for disproportionality analysis (DA), there is an increasing demand for a
Yoshihiro Noguchi +2 more
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