Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System
Sign Up to like & getrecommendations! Published in 2019 at "Targeted Oncology"
DOI: 10.1007/s11523-019-00632-w
Abstract: BackgroundImmune checkpoint inhibitors (ICIs), including antibodies targeting cytotoxic T-lymphocyte associated protein 4 (CTLA4) and programmed cell death 1 or its ligand (PD1/PDL1), elicit different immune-related adverse events (irAEs), but their global safety is incompletely characterized.ObjectiveThe… read more here.
Keywords: reporting; checkpoint inhibitors; disproportionality; pd1 pdl1 ... See more keywords
Muscular Adverse Drug Reactions Associated with Proton Pump Inhibitors: A Disproportionality Analysis Using the Italian National Network of Pharmacovigilance Database
Sign Up to like & getrecommendations! Published in 2017 at "Drug Safety"
DOI: 10.1007/s40264-017-0564-8
Abstract: IntroductionProton pump inhibitors (PPIs) have been implicated in the occurrence of moderate to severe myopathies in several case reports.AimThis study was performed to assess the reporting risk of muscular adverse drug reactions (ADRs) associated with… read more here.
Keywords: ppis; disproportionality; muscular adrs; analysis ... See more keywords
Comment on “Central Demyelinating Diseases After Vaccination Against Hepatitis B Virus: A Disproportionality Analysis Within the VAERS Database”
Sign Up to like & getrecommendations! Published in 2018 at "Drug Safety"
DOI: 10.1007/s40264-018-0733-4
Abstract: We read with interest Mouchet and Bégaud’s recent analysis of the Vaccine Adverse Events Reporting System (VAERS) database [1]. They concluded that multiple sclerosis (MS) cases were up to five times more likely to be… read more here.
Keywords: table article; disproportionality; analysis; vaers database ... See more keywords
The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration
Sign Up to like & getrecommendations! Published in 2024 at "Drug Safety"
DOI: 10.1007/s40264-024-01423-7
Abstract: In pharmacovigilance, disproportionality analyses based on individual case safety reports are widely used to detect safety signals. Unfortunately, publishing disproportionality analyses lacks specific guidelines, often leading to incomplete and ambiguous reporting, and carries the risk… read more here.
Keywords: reporting disproportionality; disproportionality; safety reports; case safety ... See more keywords
Timing Matters: A Machine Learning Method for the Prioritization of Drug–Drug Interactions Through Signal Detection in the FDA Adverse Event Reporting System and Their Relationship with Time of Co-exposure
Sign Up to like & getrecommendations! Published in 2024 at "Drug Safety"
DOI: 10.1007/s40264-024-01430-8
Abstract: Current drug–drug interaction (DDI) detection methods often miss the aspect of temporal plausibility, leading to false-positive disproportionality signals in spontaneous reporting system (SRS) databases. This study aims to develop a method for detecting and prioritizing… read more here.
Keywords: disproportionality signals; time; disproportionality; drug ... See more keywords
Neonatal withdrawal syndrome following in utero exposure to antidepressants: a disproportionality analysis of VigiBase, the WHO spontaneous reporting database.
Sign Up to like & getrecommendations! Published in 2022 at "Psychological medicine"
DOI: 10.1017/s0033291722002859
Abstract: BACKGROUND Evidence on neonatal withdrawal syndrome following antidepressant intrauterine exposure is limited, particularly for antidepressants other than selective serotonin reuptake inhibitor (SSRIs). METHODS In our case/non-case pharmacovigilance study, based on VigiBase®, the WHO database of… read more here.
Keywords: withdrawal syndrome; neonatal withdrawal; syndrome following; disproportionality ... See more keywords
A BlackCrit analysis on Black urban youth and suspension disproportionality as anti-Black symbolic violence
Sign Up to like & getrecommendations! Published in 2019 at "Race Ethnicity and Education"
DOI: 10.1080/13613324.2019.1631778
Abstract: ABSTRACT Through an analysis of Black urban high school youth’s critical engagements with literacy, the authors examine school suspensions–particularly disproportionality–as anti-Black symbolic violence. By historically mapping the terrain of discipline, from chattel slavery to The… read more here.
Keywords: disproportionality; school; youth; anti black ... See more keywords
Adverse events associated with teriparatide: a real-world disproportionality analysis of the FDA adverse event reporting system (FAERS)
Sign Up to like & getrecommendations! Published in 2024 at "Expert Opinion on Drug Safety"
DOI: 10.1080/14740338.2024.2393267
Abstract: ABSTRACT Background Teriparatide is widely used for osteoporosis treatment in various patients, but its safety profile is not fully documented. This study analyzes the FDA pharmacovigilance database to assess teriparatide’s safety. Research design and methods… read more here.
Keywords: system; adverse events; associated teriparatide; disproportionality ... See more keywords
Diabetic adverse events associated with three commonly used statins: a disproportionality analysis based on the FDA adverse event reporting system database.
Sign Up to like & getrecommendations! Published in 2024 at "Expert opinion on drug safety"
DOI: 10.1080/14740338.2024.2418325
Abstract: BACKGROUND The increasing prevalence of statin use for cardiovascular disease management has raised concerns regarding their safety profile, particularly regarding the potential risk of diabetes. Our study aims to analyze diabetic adverse event reports related… read more here.
Keywords: adverse events; fda adverse; disproportionality; adverse event ... See more keywords
Assessment of Riociguat-related adverse events: a disproportionality analysis utilizing the FDA adverse event reporting system database.
Sign Up to like & getrecommendations! Published in 2025 at "Expert opinion on drug safety"
DOI: 10.1080/14740338.2025.2466676
Abstract: BACKGROUND Riociguat is a novel soluble guanylate cyclase stimulator approved for the treatment of pulmonary arterial hypertension (PAH). Despite its widespread use, there has been a lack of large-scale studies assessing the adverse events (AEs)… read more here.
Keywords: event reporting; adverse events; fda adverse; disproportionality ... See more keywords
Using Administrative Data to Monitor Racial/Ethnic Disparities and Disproportionality Within Child Welfare Agencies: Process and Preliminary Outcomes
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Public Child Welfare"
DOI: 10.1080/15548732.2017.1301842
Abstract: ABSTRACT Child welfare administrative data are increasingly used to identify racial/ethnic disproportionality and disparities at various levels of aggregation. However, child welfare agencies typically face challenges in harnessing administrative data to examine racial/ethnic disproportionality and… read more here.
Keywords: child welfare; disproportionality; racial ethnic; administrative data ... See more keywords