Results 1 to 10 of about 588,781 (167)

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

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
exaly   +4 more sources

Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data [PDF]

Drugs - Real World Outcomes, 2023
Background Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO® Risk Evaluation and ...
Svetlana Garafola, Elizabeth Shiferaw, Vikram Dev   +2 more
doaj   +2 more sources

Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study [PDF]

Toxins, 2023
This postmarketing surveillance study was conducted to evaluate the safety and effectiveness of onabotulinumtoxinA in Japanese patients with laryngeal dystonia (LD).
Shigeomi Iimura, Yasuyo Nose, Keiko Tabata, Kenji Oda, Yoshiyuki Yamashita, Naohiro Takahashi, Yoshiaki Kawano   +6 more
doaj   +2 more sources

Postmarketing surveillance of elobixibat for patients with chronic constipation and concomitant schizophrenia or depression in Japan [PDF]

Frontiers in Psychiatry
BackgroundLittle is known about the optimal treatment for constipation in patients with schizophrenia or depression. Elobixibat is a laxative with a novel mechanism of action that inhibits the ileal bile acid transporter, acting as both an osmotic and a ...
Yoshiteru Takekita, Minami Umeyama, Mie Iwaida, Masaaki Higashikawa, Yusuke Shimada, Atsushi Nakajima   +5 more
doaj   +2 more sources

Idarucizumab for Emergency Reversal of the Anticoagulant Effects of Dabigatran: Final Results of a Japanese Postmarketing Surveillance Study [PDF]

Cardiology and Therapy, 2023
Introduction Idarucizumab, a monoclonal antibody fragment that rapidly reverses the anticoagulant effects of dabigatran, was approved in Japan in September 2016, at which time an all-case, postmarketing surveillance (PMS) study was initiated to collect ...
Masahiro Yasaka, Hiroyuki Yokota, Michiyasu Suzuki, Hidesaku Asakura, Teiichi Yamane, Yukako Ogi, Takaaki Kimoto, Daisuke Nakayama   +7 more
doaj   +2 more sources

Real‐World Outcomes of Avelumab Maintenance Therapy in Patients With Curatively Unresectable Urothelial Carcinoma in Japan: Results From the Final Analysis of Postmarketing Surveillance [PDF]

Cancer Medicine
Background Avelumab maintenance therapy was approved in Japan in February 2021 for the treatment of curatively unresectable urothelial carcinoma (UC) that has not progressed after prior chemotherapy based on results from the JAVELIN Bladder 100 phase 3 ...
Eiji Kikuchi, Masayoshi Nagata, Taito Ito, Masashi Sato, Mie Ogi, Makiko Morita, Masahiro Kajita, Hiroyuki Nishiyama   +7 more
doaj   +2 more sources

A multicenter, postmarketing surveillance of elobixibat in patients with chronic constipation in Japan: A final analysis report [PDF]

SAGE Open Medicine
Objective: An interim analysis of postmarketing surveillance reported the safety and efficacy of elobixibat, a laxative medication that inhibits the ileal bile acid transporter, at 4 weeks in approximately 1000 patients with chronic constipation in Japan.
Atsushi Nakajima, Minami Umeyama, Masaaki Higashikawa, Yusuke Shimada, Yuki Arai   +4 more
doaj   +2 more sources

Characteristics of Phase IV Clinical Trials in Oncology: An Analysis Using the ClinicalTrials.gov Registry Data

Current Oncology, 2023
The present study analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics ...
Brandon Michael Henry, Giuseppe Lippi, Ameen Nasser, Patryk Ostrowski   +3 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

Monitoring temporal changes in the specificity of an oral HIV test: a novel application for use in postmarketing surveillance. [PDF]

PLoS ONE, 2010
BackgroundPostmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devices in the marketplace. However, these surveillance methods are often done retrospectively and, as a result, are not designed to detect ...
Joseph R Egger, Kevin J Konty, Jessica M Borrelli, Julia Cummiskey, Susan Blank   +4 more
doaj   +1 more source