Results 31 to 40 of about 786,314 (373)

A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for niraparib

Scientific Reports, 2022
Niraparib was approved for the treatment of platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The authors retrospectively investigated niraparib-related adverse events (AEs) through data mining of the ...
Menglin Guo, Yamin Shu, Guosong Chen, Juan Li, Fei 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 Safety Concerns With Secukinumab: A Disproportionality Analysis of the FDA Adverse Event Reporting System

Frontiers in Pharmacology, 2022
Purpose: Secukinumab was approved for the treatment of psoriasis, psoriatic arthritis, and ankylosing spondylitis. However, the long-term safety of secukinumab in large sample population was unknown.
Yamin Shu, Yufeng Ding, Yanxin Liu, Pan Wu, Xucheng He, Qilin Zhang   +5 more
semanticscholar   +1 more source

Publicity and reports of behavioral addictions associated with dopamine agonists [PDF]

, 2015
Background The development of behavioral addictions (BAs) in association with dopamine agonists (DAs, commonly used to treat Parkinson’s disease) has been reported.
Gendreau, Katherine E., Potenza, Marc N.
core   +1 more source

Gastrointestinal adverse events associated with semaglutide: A pharmacovigilance study based on FDA adverse event reporting system

Frontiers in Public Health, 2022
Background Semaglutide was approved for treatment of type 2 diabetes mellitus (T2DM) and chronic weight management in obesity or overweight adults. However, real-world data regarding its long-term gastrointestinal safety and tolerability in large sample ...
Yamin Shu, Xucheng He, Pan Wu, Yanxin Liu, Yufeng Ding, Qilin Zhang   +5 more
semanticscholar   +1 more source

Adverse Effects of Cholinesterase Inhibitors in Dementia, According to the Pharmacovigilance Databases of the United-States and Canada. [PDF]

, 2015
This survey analyzes two national pharmacovigilance databases in order to determine the major adverse reactions observed with the use of cholinesterase inhibitors in dementia.
Abagyan, Ruben, Ali, Thibault B, Chen, Winston Yuchen, Reilly, Brian M, Schleret, Thomas R   +4 more
core   +3 more sources

Assessment of Reye’s syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis

SAGE Open Medicine, 2020
Objectives: Reye’s syndrome is a rare and potentially fatal illness that is defined as encephalopathy accompanied by liver failure. The aim of this study was to assess Reye’s syndrome profiles by analyzing data from the spontaneous reporting system ...
Kiyoka Matsumoto, Shiori Hasegawa, Satoshi Nakao, Kazuyo Shimada, Ririka Mukai, Mizuki Tanaka, Riko Satake, Yu Yoshida, Fumiya Goto, Misaki Inoue, Hiroaki Ikesue, Kazuhiro Iguchi, Tohru Hashida, Mitsuhiro Nakamura   +13 more
doaj   +1 more source

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

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

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
core   +3 more sources