Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.
Sign Up to like & getrecommendations! Published in 2021 at "JAMA internal medicine"
DOI: 10.1001/jamainternmed.2021.3942
Abstract: Importance In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database.… read more here.
Keywords: event reports; death; adverse event; medical device ... See more keywords
Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017
Sign Up to like & getrecommendations! Published in 2019 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2019.9249
Abstract: Key Points Question What is the postmarketing safety profile of sipuleucel-T in the United States? Findings The US Food and Drug Administration’s Adverse Event Reporting System received 3216 reports for sipuleucel-T from 2010 through 2017.… read more here.
Keywords: reporting; administration adverse; adverse event; drug administration ... See more keywords
Association of Preprocedural Fasting With Outcomes of Emergency Department Sedation in Children
Sign Up to like & getrecommendations! Published in 2018 at "JAMA Pediatrics"
DOI: 10.1001/jamapediatrics.2018.0830
Abstract: Importance It is not clear whether adherence to preprocedural fasting guidelines prevent pulmonary aspiration and associated adverse outcomes during emergency department (ED) sedation of children. Objective To examine the association between preprocedural fasting duration and… read more here.
Keywords: adverse event; serious adverse; sedation; adverse events ... See more keywords
Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.2074
Abstract: We improved a previous pharmacological target adverse‐event (TAE) profile model to predict adverse events (AEs) on US Food and Drug Administration (FDA) drug labels at the time of approval. The new model uses more drugs… read more here.
Keywords: event; adverse event; drug labels; target adverse ... See more keywords
Observed-over-Expected analysis as additional method for pharmacovigilance signal detection in large-scaled spontaneous adverse event reporting.
Sign Up to like & getrecommendations! Published in 2023 at "Pharmacoepidemiology and drug safety"
DOI: 10.1002/pds.5610
Abstract: BACKGROUND The large-scale COVID-19 vaccination campaigns in 2021 and 2022 led to a rapid increase in numbers of received adverse event reports in spontaneous reporting systems. As background incidences of naturally occurring medical events became… read more here.
Keywords: signal detection; adverse event; detection; analysis ... See more keywords
Mining adverse events in large frequency tables with ontology, with an application to the vaccine adverse event reporting system
Sign Up to like & getrecommendations! Published in 2023 at "Statistics in Medicine"
DOI: 10.1002/sim.9684
Abstract: Many statistical methods have been applied to VAERS (vaccine adverse event reporting system) database to study the safety of COVID‐19 vaccines. However, none of these methods considered the adverse event (AE) ontology. The AE ontology… read more here.
Keywords: event reporting; vaccine adverse; adverse event; ontology ... See more keywords
Bayesian generalized linear low rank regression models for the detection of vaccine‐adverse event associations
Sign Up to like & getrecommendations! Published in 2023 at "Statistics in Medicine"
DOI: 10.1002/sim.9711
Abstract: We propose a generalized linear low‐rank mixed model (GLLRM) for the analysis of both high‐dimensional and sparse responses and covariates where the responses may be binary, counts, or continuous. This development is motivated by the… read more here.
Keywords: generalized linear; regression; event; vaccine adverse ... See more keywords
From Harmful Treatment to Secondary Gain: Adverse Event Reporting in Dyspepsia and Gastroparesis
Sign Up to like & getrecommendations! Published in 2017 at "Digestive Diseases and Sciences"
DOI: 10.1007/s10620-017-4633-8
Abstract: IntroductionMedical management of gastroparesis and functional dyspepsia remains difficult with several recent trials showing limited or no benefit. If treatment comes with only marginal improvements, concerns about adverse events become more relevant. We therefore examined… read more here.
Keywords: adverse event; dyspepsia gastroparesis; treatment; event reporting ... See more keywords
Adverse Event Fatalities Related to GI Endoscopy
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DOI: 10.1007/s10620-021-06981-9
Abstract: Death after endoscopy is rare, under-reported, and has variable causes. This study aimed to evaluate the incidence and causes of fatal endoscopic adverse events (AEs) across two academic medical centers and to identify patient-, procedure-,… read more here.
Keywords: event fatalities; adverse event; procedure; related endoscopy ... See more keywords
A Survey of the FDA’s Adverse Event Reporting System Database Concerning Urogenital Tract Infections and Sodium Glucose Cotransporter‐2 Inhibitor Use
Sign Up to like & getrecommendations! Published in 2019 at "Diabetes Therapy"
DOI: 10.1007/s13300-019-0611-9
Abstract: IntroductionWe tested the possible association between sodium glucose cotransporter-2 inhibitor (SGLT-2i) use and urogenital tract infection (UTI) occurrences by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS).MethodsDisproportionality analysis and… read more here.
Keywords: adverse event; sodium glucose; use; urogenital tract ... See more keywords
Myocarditis and pericarditis after immunization: Gaining insights through the Vaccine Adverse Event Reporting System.
Sign Up to like & getrecommendations! Published in 2018 at "International journal of cardiology"
DOI: 10.1016/j.ijcard.2018.09.054
Abstract: Abstract Aim To characterize cases of myocarditis (MC) and pericarditis (PC) recorded in the Vaccine Adverse Event Reporting System (VAERS). Methods Cases were extracted from VAERS (2011–2015) and assessed for causality using standardized WHO algorithm.… read more here.
Keywords: adverse event; reporting system; event reporting; vaccine adverse ... See more keywords