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
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
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
Antidepressants-related cardiovascular adverse events using the adverse event reporting system
Sign Up to like & getrecommendations! Published in 2018 at "Psychiatry Research"
DOI: 10.1016/j.psychres.2018.07.044
Abstract: The aim of this study was to evaluate clinical manifestations and the age and sex distribution of cardiovascular adverse events (CVAEs) related to antidepressants. The FDA Adverse Event Reporting System (FAERS) and Korea Adverse Event… read more here.
Keywords: reporting system; reporting; adverse event; event reporting ... See more keywords
Signals and trends of Guillain-Barré syndrome after the introduction of live-attenuated vaccines for influenza in the US and South Korean adverse event reporting systems.
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DOI: 10.1016/j.vaccine.2020.06.038
Abstract: BACKGROUND With the advent of live-attenuated, quadrivalent, and cell-cultured vaccines for influenza, there have been discussions on the safety of these vaccines compared to conventional vaccines (such as inactivated, trivalent, and egg-cultured vaccines) because of… read more here.
Keywords: adverse event; reporting systems; vaccines influenza; event reporting ... See more keywords
Adverse event reporting patterns of concomitant botanical dietary supplements with CYP3A4 interactive & CYP3A4 non-interactive anticancer drugs in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS)
Sign Up to like & getrecommendations! Published in 2019 at "Expert Opinion on Drug Safety"
DOI: 10.1080/14740338.2019.1562546
Abstract: ABSTRACT Background: To examine the adverse event (AE) reporting patterns for concomitant Botanical Dietary Supplements (BDS) and anticancer drugs. Research design and methods: Using the 2004–2015 U.S. Food and Drug Administration Adverse Event Reporting System… read more here.
Keywords: anticancer drugs; anticancer; adverse event; event reporting ... See more keywords
The Relationship Between Safety Culture and Voluntary Event Reporting in a Large Regional Ambulatory Care Group
Sign Up to like & getrecommendations! Published in 2017 at "Journal of Patient Safety"
DOI: 10.1097/pts.0000000000000337
Abstract: Objectives The safety culture in the workplace may affect event reporting. We evaluated the relationship of safety culture and voluntary event reporting within a large network of ambulatory practices, most of which provided primary care.… read more here.
Keywords: safety culture; culture; safety; event reporting ... See more keywords
Challenges and Barriers to Adverse Event Reporting in Clinical Trials: A Children’s Oncology Group Report
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DOI: 10.1097/pts.0000000000000911
Abstract: Objective Adverse event (AE) reporting is crucial for determining safety of trials. Adverse events are captured manually by clinical research associates (CRAs) and research nurses (RNs), and prior studies show underreporting. It is necessary to… read more here.
Keywords: children oncology; adverse event; report; event reporting ... See more keywords
Disparities in Adverse Event Reporting for Hospitalized Children
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DOI: 10.1097/pts.0000000000001049
Abstract: Objectives Hospitals rely on voluntary event reporting (VER) for adverse event (AE) identification, although it captures fewer events than a trigger tool, such as Global Assessment of Pediatric Patient Safety (GAPPS). Medical providers exhibit bias… read more here.
Keywords: hospitalized children; event reporting; event; gapps ... See more keywords
Integrating Adverse Event Reporting Into a Free-Text Mobile Application Used in Daily Workflow Increases Adverse Event Reporting by Physicians
Sign Up to like & getrecommendations! Published in 2019 at "American Journal of Medical Quality"
DOI: 10.1177/1062860619891995
Abstract: Adverse event (AE) reporting is a key component of patient safety and physicians are known to underreport. The authors hypothesized that integrating AE reporting into a mobile application used in daily physician workflow would increase… read more here.
Keywords: used daily; adverse event; event reporting; mobile application ... See more keywords
Commentary on Perez et al.: How to create a 21st century adverse event reporting system
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DOI: 10.1177/1740774517700641
Abstract: Adverse event reporting for patients on clinical trials has two main purposes: (1) informing sponsors and regulators of potential new risks of a given agent and (2) informing patients and investigators of those risks. While… read more here.
Keywords: adverse event; event reporting; clinical trials; oncology ... See more keywords