Results 31 to 40 of about 1,331,435 (262)

Ontology Modelling for FDA Adverse Event Reporting System [PDF]

, 2016
Ontologies are relevant to a specific knowledge or application domain and it represents a set of concepts and their inter-relationships. Ontological design comprises of ontology development process, the ontology life cycle, the techniques and ...
, Rima Borah, Rajarajeswari S.
core   +2 more sources

Adverse drug event reporting systems: a systematic review [PDF]

British Journal of Clinical Pharmacology, 2016
AimAdverse drug events (ADEs) are harmful and unintended consequences of medications. Their reporting is essential for drug safety monitoring and research, but it has not been standardized internationally. Our aim was to synthesize information about the type and variety of data collected within ADE reporting systems.MethodsWe developed a systematic ...
David Peddie, David Peddie, Maeve E. Wickham, Maeve E. Wickham, Ellen Balka, Ellen Balka, Mary M. Doyle-Waters, Katherin Badke, Katherin Badke, Chantelle Bailey, Chantelle Bailey, Corinne M. Hohl, Corinne M. Hohl, Serena S Small, Serena S Small   +14 more
openaire   +2 more sources

A pharmacovigilance analysis of FDA adverse event reporting system events for romosozumab

Expert Opinion on Drug Safety, 2022
Romosozumab is a novel drug for the treatment of osteoporosis. The adverse reactions of romosozumab still need to be explored. The FDA Adverse Event Reporting System (FAERS) provides an enormous dataset for adverse events (AEs) analysis. AEs registered in FAERS between January 2019 and December 2020 were collected for this study.
Zepeng Chen, Ming Li, Shuzhen Li, Yuxi Li, Junyan Wu, Kaifeng Qiu, Xiaoxia Yu, Lin Huang, Guanghui Chen   +8 more
openaire   +2 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

A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system

Frontiers in Pharmacology, 2023
Background: Apalutamide is a new drug class, which is approved to treat prostate cancer (PCa). The aim of our study was to assess the safety profiles of apalutamide in real-world through data mining of the United States Food and Drug Administration ...
Zhihong Fang, Zhiqiang Xu, Wei Zhu, Mingming Yu, Chunmei Ji   +4 more
doaj   +1 more source

Colistin-associated Stevens-Johnson syndrome and toxic epidermal necrolysis reactions: a retrospective case-non-case pharmacovigilance study [PDF]

, 2022
Background: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening skin reactions. Colistin is a last resort antibiotic with a historically poor safety profile.
Caffrey, Aisling R, Lopes, Vrishali L., Tang, Richard   +2 more
core   +1 more source

Adverse Events Related to Off-Label Drugs Using Spontaneous Adverse Event Reporting Systems

Therapeutics and Clinical Risk Management, 2021
The purpose of this study was to investigate the adverse events (AEs) related to the use of off-label drugs.A cross-sectional study was carried out using available data pertaining to off-label drug were sourced from U.S. FDA spontaneous adverse drug reaction reporting database (FAERS) and Korea Adverse Event Reporting System database (KIDS-KD) for the ...
In-Wha Kim, Nayoung Han, Nayoung Han, Jung Mi Oh   +3 more
openaire   +5 more sources

Adverse event profiles of solvent-based and nanoparticle albumin-bound paclitaxel formulations using the Food and Drug Administration Adverse Event Reporting System

SAGE Open Medicine, 2019
Objectives: Paclitaxel is a highly effective antitumor agent with notable adverse events, including hypersensitivity reactions, peripheral neuropathy, arthralgia, myalgias, and neutropenia.
Misa Naganuma, Kohei Tahara, Shiori Hasegawa, Akiho Fukuda, Sayaka Sasaoka, Haruna Hatahira, Yumi Motooka, Satoshi Nakao, Ririka Mukai, Kouseki Hirade, Tomoaki Yoshimura, Takeshi Kato, Hirofumi Takeuchi, Mitsuhiro Nakamura   +13 more
doaj   +1 more source

Indication and adverse event profiles of denosumab and zoledronic acid: based on U.S. FDA adverse event reporting system (FAERS)

Frontiers in Pharmacology, 2023
Objective: To investigate adverse events (AEs) associated with denosumab (Dmab) and zoledronic acid (ZA), compare their association strengths, and explore potential applications to provide clinical reference.Methods: We collected data from FAERS from ...
Si Su, Si Su, Liuqing Wu, Guibao Zhou, Lingling Peng, Huanzhe Zhao, Xiao Wang, Xiao Wang, Kuan Li   +8 more
doaj   +1 more source

Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

Saudi Medical Journal, 2015
To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications.A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS.
Waad H. Al-Kathiri, Hervé Le Louet, Hisham Aljadhey, Thamir M. Alshammari   +3 more
openaire   +3 more sources