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Drug-induced hypoglycemia: a disproportionality analysis of the FAERS database

Expert Opinion on Drug Safety, 2023
Hypoglycemia is an adverse event (AE) that cannot be ignored in clinical practice. This study aimed to identify the most common and top drugs associated with the risk of hypoglycemia based on the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.We used OpenVigil 2.1 pharmacovigilance analytics platform to
Jie, Li   +4 more
openaire   +2 more sources

Kinetic analysis of the disproportionation of aqueous glyoxal

International Journal of Chemical Kinetics, 1986
AbstractRates of disproportionation of 0.015–0.4 mM aqueous glyoxal toglycolic acid were measured at 0.24–75 mM NaOH and constant ionic strength, leading to the empirical rate expression r = (a1[OH−] + a2[OH−]2) [GT]/(1 + a3[OH−]), where [GT] is the total glyoxal concentration. These results were confirmed in bicarbonate/carbonate buffer and at 2–20 mM
Alfred R. Fratzke, Peter J. Reilly
openaire   +1 more source

Disproportionate Samples in Hierarchical Bayes CBC Analysis

2007
Empirical 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
openaire   +1 more source

Disproportionality Analysis and Causal Inference in Drug Safety

Pharmaceutical Medicine
Disproportionality 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
openaire   +2 more sources

Detection of signals of abuse and dependence applying disproportionality analysis

European Journal of Clinical Pharmacology, 2014
Prescription 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
openaire   +2 more sources

Drug-induced hyperacusis: a disproportionality analysis of the FAERS database

Expert Opinion on Drug Safety
Hyperacusis 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
openaire   +2 more sources

Caveats of Covariate Adjustment in Disproportionality Analysis for Best Practices

Drug Safety
Spontaneous 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
openaire   +2 more sources

The safety profile of azithromycin in pediatrics: a pharmacovigilance disproportionality analysis

Expert Opinion on Drug Safety
To 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
openaire   +2 more sources

Adverse Reaction Signaling and Disproportionality Analysis: An Update

Drug Information Journal, 2012
There 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
openaire   +1 more source

Effect of consumer reporting on signal detection: using disproportionality analysis

Expert Opinion on Drug Safety, 2007
Pharmacovigilance objectives and activities are designed to protect the health of consumers and are generally based on data acquisition from spontaneous adverse event reports (SADRs). SADRs come from different sources, including healthcare professionals, consumers, lawyers, other pharmaceutical companies, regulatory agencies and so on ...
Isaac W, Hammond   +2 more
openaire   +2 more sources

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