Results 11 to 20 of about 21,353 (254)

Real-world safety and effectiveness of alemtuzumab for relapsed or refractory chronic lymphocytic leukaemia: results from postmarketing surveillance in Japan. [PDF]

Jpn J Clin Oncol
Sasakura Y, Hatanaka M, Ishizawa K.
europepmc   +3 more sources

Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis. [PDF]

PLoS ONE, 2016
BACKGROUND:Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention.
Kazuo Iijima, Mitsuo Umezu, Kiyotaka Iwasaki   +2 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

PROVE: Retrospective, non‐interventional, Phase IV study of perampanel in real‐world clinical care of patients with epilepsy

Epilepsia Open, 2022
Objective To assess retention, dosing, efficacy, and safety of perampanel in a large cohort of patients with epilepsy during routine clinical care. Methods PROVE was a retrospective, non‐interventional Phase IV study (NCT03208660).
Robert T. Wechsler, James Wheless, Muhammad Zafar, Graham R. Huesmann, Marcelo Lancman, Eric Segal, Michael Chez, Sami Aboumatar, Anna Patten, Alejandro Salah, Manoj Malhotra   +10 more
doaj   +1 more source

Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study

BMJ Open, 2023
Objective We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA ...
Yi Chen, Yue Liu, Yifei Wang, Rong Jiang, Yifan Yang, Jinping Xie, Jinlian Li, Haoyang Wang, Rong Shao   +8 more
doaj   +1 more source

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Frontiers in Pharmacology, 2022
Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in ...
Jinyi Yuan, Xiaoping Zhang, Jing Chen, Yueyuan Zhang, Fengjia Zhu, Haihui Huang   +5 more
doaj   +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

Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018

Orphanet Journal of Rare Diseases, 2022
Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan
Min Fan, Adrienne Y. L. Chan, Vincent K. C. Yan, Xinning Tong, Lauren K. W. Lau, Eric Y. F. Wan, Eliza Y. T. Tam, Patrick Ip, Terry Y. Lum, Ian C. K. Wong, X. Li   +10 more
doaj   +1 more source

Sleep-walking with zolpidem: Need for continued postmarketing surveillance

Indian Journal of Psychological Medicine, 2015
Ajitha Sharma, S Rama Prakasha
doaj   +2 more sources

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