Results 31 to 40 of about 1,261,156 (366)

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for osimertinib

Scientific Reports, 2022
Osimertinib was a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), which approved by the US Food and Drug Administration (FDA) in 2015 for treatment of non-small cell lung cancer (NSCLC). Our study was
Yanchao Yin, Yamin Shu, Junru Zhu, Fei Li, Juan Li   +4 more
semanticscholar   +1 more source

Distributed Ledger Infrastructure to Verify Adverse Event Reporting (DeLIVER): Proposal for a Proof-of-Concept Study

JMIR Research Protocols, 2021
BackgroundAdverse drug event reporting is critical for ensuring patient safety; however, numbers of reports have been declining. There is a need for a more user-friendly reporting system and for a means of verifying reports that have been filed.
Milne-Ives, Madison, Lam, Ching, Rehman, Najib, Sharif, Raja, Meinert, Edward   +4 more
doaj   +1 more source

Post-Marketing Surveillance of CAR-T-Cell Therapies: Analysis of the FDA Adverse Event Reporting System (FAERS) Database

Drug Safety, 2022
As chimeric antigen receptor T-cell therapies are becoming increasingly available in the armamentarium of the hematologist, there is an emerging need to monitor post-marketing safety.
M. Fusaroli, Valentina Isgró, P. Cutroneo, C. Ferrajolo, Valentina Cirillo, F. del Bufalo, E. Raschi, E. Poluzzi, G. Trifirò   +8 more
semanticscholar   +1 more source

Evaluating Ubrogepant-related adverse events using the FDA adverse event reporting system

Expert Opinion on Drug Safety, 2023
Migraine has a high prevalence in the population and accounts for 12% of primary headaches. Ubrogepant is used for the treatment of acute migraine, and although some clinical trials have demonstrated the safety of Ubrogepant, its long-term safety in a large sample of the population remains to be investigated. We collected data from the US Food and Drug
Bing, Cao, Shanshan, Gu, Zhisen, Shen, Yuna, Zhang, Yiming, Shen, Hang, Chen   +5 more
openaire   +2 more sources

Antifungal Drugs and Drug-Induced Liver Injury: A Real-World Study Leveraging the FDA Adverse Event Reporting System Database

Frontiers in Pharmacology, 2022
Aims: We aimed to estimate the risk of drug-induced liver injury (DILI) from various antifungal treatments with azoles and echinocandins causing in real-world practice. Methods: We performed disproportionality and Bayesian analyses based on data from the
Zhi-xuan Zhou, Xue-dong Yin, Yu Zhang, Qi-hui Shao, X. Mao, Wen-juan Hu, Yunfang Shen, Bin Zhao, Zhi-ling Li   +8 more
semanticscholar   +1 more source

Thromboembolic events in Janus kinase inhibitors: A pharmacovigilance study from 2012 to 2021 based on the Food and Drug Administration's Adverse Event Reporting System

British Journal of Clinical Pharmacology, 2022
As a new type of drug developed rapidly in recent years, Janus kinase inhibitors (JAKinibs) have caused controversy due to possible adverse reactions of thromboembolism.
Ziwei Dong, X. Ye, Chenxin Chen, Rui Wang, Dongxu Liu, Xiao Xu, Xiang Zhou, Jia He   +7 more
semanticscholar   +1 more source

Impulse Control Disorders by Dopamine Partial Agonists: A Pharmacovigilance-Pharmacodynamic Assessment Through the FDA Adverse Event Reporting System

International Journal of Neuropsychopharmacology, 2022
Background The dopaminergic partial agonism of the so-called third-generation antipsychotics (TGAs; aripiprazole, brexpiprazole, cariprazine) is hypothesized to cause impulse control disorders (ICDs). Relevant warnings by the Food and Drug Administration
M. Fusaroli, E. Raschi, V. Giunchi, M. Menchetti, Roberto Rimondini Giorgini, F. De Ponti, E. Poluzzi   +6 more
semanticscholar   +1 more source

AE-GPT: Using Large Language Models to Extract Adverse Events from Surveillance Reports-A Use Case with Influenza Vaccine Adverse Events [PDF]

, 2023
Though Vaccines are instrumental in global health, mitigating infectious diseases and pandemic outbreaks, they can occasionally lead to adverse events (AEs). Recently, Large Language Models (LLMs) have shown promise in effectively identifying and cataloging AEs within clinical reports.
arxiv   +1 more source

Simulating adverse event spontaneous reporting systems as preferential attachment networks [PDF]

Applied Clinical Informatics, 2014
Summary Background: Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases.
Robert Ball, Taxiarchis Botsis, John Scott   +2 more
openaire   +3 more sources

Primary extranodal diffuse large B‐cell lymphoma: Molecular features, treatment, and prognosis

Aging and Cancer, Volume 3, Issue 3-4, Page 133-146, September-December 2022., 2022
One‐third of DLBCL arises from extranodal organs and is challenging to manage. Molecular features are critical to elucidate the differences in clinical features, predict the disease prognosis, and improve effective targeted therapeutic strategies. Abstract Diffuse large B‐cell lymphoma (DLBCL) is the most common subtype of non‐Hodgkin's lymphoma and ...
Si‐Yuan Chen, Meng‐Meng Ji, Peng‐Peng Xu, Wei‐Li Zhao   +3 more
wiley   +1 more source