Results 21 to 30 of about 25,471 (263)

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Archives of medical science : AMS, 2021
Introduction In the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high ...
M. Banach, N. Katsiki, G. Latkovskis, M. Rizzo, D. Pella, Peter E. Penson, Ž. Reiner, A. Cicero   +7 more
semanticscholar   +1 more source

Real‐world safety of nivolumab in patients with non‐small‐cell lung cancer in Japan: Postmarketing surveillance

Cancer Science, 2021
Postmarketing surveillance of Japanese patients with unresectable, previously treated, advanced or recurrent non‐small‐cell lung cancer treated with nivolumab was undertaken during the conditional approval period.
N. Yamamoto, Y. Nakanishi, A. Gemma, K. Nakagawa, Takahiko Sakamoto, Ayumi Akamatsu, Y. Ohe   +6 more
semanticscholar   +1 more source

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Frontiers in Medicine, 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) has conducted many pharmacoepidemiological studies for postmarketing drug safety assessments based on real-world data from medical information databases.
Haruka Shida, Kazuhiro Kajiyama, Sono Sawada, Chieko Ishiguro, Mikiko Kubo, Ryota Kimura, Mai Hirano, Noriyuki Komiyama, Toyotaka Iguchi, Yukio Oniyama, Yoshiaki Uyama   +10 more
doaj   +1 more source

First‐Line Osimertinib in Patients with EGFR‐Mutant Advanced Non‐Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study

The Oncologist, EarlyView., 2021
Abstract Lessons Learned Osimertinib has confirmed effectiveness in this real‐world population of patients with EGFR‐mutant advanced non‐small cell lung cancer. Thromboembolic events occur more frequently than previously reported, suggesting a thrombotic diathesis that requires further investigation. Patients with at least three metastatic sites, brain
Martina Lorenzi, Alessandra Ferro, Fabiana Cecere, Daniela Scattolin, Alessandro Del Conte, Alessandro Follador, Sara Pilotto, Valentina Polo, Mariacarmela Santarpia, Rita Chiari, Alberto Pavan, Alessandro Dal Maso, Valentina Da Ros, Giada Targato, Sabrina Vari, Stefano Indraccolo, Fiorella Calabrese, Stefano Frega, Laura Bonanno, Pier Franco Conte, Valentina Guarneri, Giulia Pasello   +21 more
wiley   +1 more source

Safety of Gliadel Implant for Malignant Glioma: Report of Postmarketing Surveillance in Japan

Neurologia medico-chirurgica, 2021
Clinical trial data of Carmustine implant (Gliadel Wafer) in Japanese patients with malignant glioma are limited; thus, we conducted a postmarketing surveillance study to evaluate the safety of Gliadel in real-world clinical practice in Japan.
R. Nishikawa, H. Iwata, Y. Sakata, K. Muramoto, T. Matsuoka   +4 more
semanticscholar   +1 more source

Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]

, 2018
BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron, Avant, Debbie, Baer, Gerri, Burckart, Gilbert J., Moore, Jason N., Sorbello, Alfred, Wang, Jian, Yao, Lynne, Zheng, Panli   +8 more
core   +3 more sources

Tocilizumab in rheumatoid arthritis: A case study of safety evaluations of a large postmarketing data set from multiple data sources [PDF]

, 2015
ObjectivesTo evaluate the magnitude of serious adverse events (SAEs) observed in postmarketing reports of tocilizumab (TCZ) for rheumatoid arthritis (RA) in relation to SAEs observed in TCZ clinical trials and external epidemiology data.MethodsA total of
Curtis, Jeffrey R., Napalkov, Pavel, Perez-Gutthann, Susana, Porter-Brown, Benjamin, Singh, Natasha, Suissa, Samy, Thompson, Liz   +6 more
core   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

Associations With Definitive Outcomes and Clinical Benefit of Cancer Drugs at the Time of Marketing Approval and in the Postmarketing Period.

The Journal of the National Comprehensive Cancer Network, 2021
BACKGROUND Most anticancer drugs are approved by regulatory agencies based on surrogate measures. This article explores the variables associated with overall survival (OS), quality of life (QoL), and substantial clinical benefit among anticancer drugs at
A. Bujosa, C. Moltó, T. Hwang, J. C. Tapia, K. Vokinger, A. Templeton, I. Gich, A. Barnadas, E. Amir, A. Tibau   +9 more
semanticscholar   +1 more source

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y., Fogg, Carole, Layton, D., Shakir, S.   +3 more
core   +1 more source