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   Articles with "adverse event" as a keyword



Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.

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recommendations! 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
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Adverse Events Associated With the Use of Sipuleucel-T Reported to the US Food and Drug Administration’s Adverse Event Reporting System, 2010-2017

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recommendations! 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

Hospital COVID-19 Burden and Adverse Event Rates

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recommendations! Published in 2024 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2024.42936

Abstract: This cohort study examines whether hospital COVID-19 burden was associated with rates of in-hospital adverse events among Medicare patients during the COVID-19 pandemic. read more here.

Keywords: hospital covid; burden adverse; adverse event; covid burden ... See more keywords

Adverse Event Costs and Cost-Effectiveness Analyses of Anticancer Drugs

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recommendations! Published in 2025 at "JAMA Network Open"

DOI: 10.1001/jamanetworkopen.2025.12455

Abstract: This systematic review examines whether adverse event costs in cost-effectiveness analyses of anticancer drugs accurately reflect costs reported in claims-based studies. read more here.

Keywords: costs cost; analyses anticancer; adverse event; event costs ... See more keywords

Association of Preprocedural Fasting With Outcomes of Emergency Department Sedation in Children

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recommendations! 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

Exploring the Relationship Between Antipsychotic Drug Target Genes and Epilepsy: Evidence From Food and Drug Administration Adverse Event Reporting System Database and Mendelian Randomization

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recommendations! Published in 2025 at "Brain and Behavior"

DOI: 10.1002/brb3.70467

Abstract: The effect of antipsychotic drugs on epilepsy is controversial, and we performed Food and Drug Administration Adverse Event Reporting System (FAERS) data mining and Mendelian Randomization (MR) analyses to clarify the effects of target genes… read more here.

Keywords: event reporting; food drug; drug; adverse event ... See more keywords

Cardiovascular and Metabolic Adverse Events of Endocrine Therapies in Women with Breast Cancer: A Disproportionality Analysis of Reports in the FDA Adverse Event Reporting System

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recommendations! Published in 2024 at "Cancer Medicine"

DOI: 10.1002/cam4.70548

Abstract: Emerging evidence suggests potential cardiovascular toxicities from oral endocrine therapies (ETs); however, results are conflicting. This study comprehensively examined adverse reactions of ETs and investigated cardiovascular and metabolic safety signals within the FDA Adverse Event… read more here.

Keywords: event reporting; fda adverse; reporting system; adverse event ... See more keywords

Target Adverse Event Profiles for Predictive Safety in the Postmarket Setting

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recommendations! 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.

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recommendations! 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

Adverse Event Assessment of Upadacitinib: A Pharmacovigilance Study Based on the FAERS Database

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recommendations! Published in 2024 at "Pharmacoepidemiology and Drug Safety"

DOI: 10.1002/pds.70030

Abstract: Upadacitinib, a Janus kinase (JAK) inhibitor, has been approved by the FDA to treat various autoimmune conditions. This study assessed its adverse events by analyzing reports from the FDA Adverse Event Reporting System (FAERS). read more here.

Keywords: upadacitinib pharmacovigilance; event; adverse event; assessment upadacitinib ... See more keywords

Validation of Immune‐Related Adverse Event (irAE) Case Definitions in a Real‐World Lung Cancer Population

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recommendations! Published in 2025 at "Pharmacoepidemiology and Drug Safety"

DOI: 10.1002/pds.70100

Abstract: The use of real‐world data is increasing to examine immune‐related adverse event (irAE) incidence and risk factors in immune checkpoint inhibitor (ICI) users. We aimed to validate five case definition algorithms for irAE in a… read more here.

Keywords: related adverse; lung cancer; real world; adverse event ... See more keywords