Postmarketing surveillance on the clinical use of edoxaban in patients with nonvalvular atrial fibrillation (ETNA‐AF‐Japan): One‐year safety and effectiveness analyses
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DOI: 10.1002/joa3.12332
Abstract: The safety and effectiveness of edoxaban in real‐world clinical settings have not yet been elucidated thoroughly among Japanese patients with nonvalvular atrial fibrillation (NVAF). We report the one‐year interim results of ETNA‐AF‐Japan (Edoxaban Treatment in… read more here.
Keywords: atrial fibrillation; nonvalvular atrial; year; safety effectiveness ... See more keywords
Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two‐year postmarketing surveillance study (ETNA‐AF‐Japan)
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DOI: 10.1002/joa3.12520
Abstract: Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, the safety and effectiveness of edoxaban for this indication requires monitoring over the long… read more here.
Keywords: atrial fibrillation; nonvalvular atrial; safety effectiveness; effectiveness edoxaban ... See more keywords
A feasibility assessment of real-world data capabilities for monitoring vaccine safety and effectiveness in China: human papillomavirus vaccination in the Yinzhou district as a use case.
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DOI: 10.1002/pds.5644
Abstract: BACKGROUND Real-world data (RWD) are increasingly used to generate real-world evidence (RWE) of vaccine safety and effectiveness for regulatory purposes. Assessing feasibility of using RWD sources prior to implementing observational studies is recommended. As a… read more here.
Keywords: safety; feasibility assessment; vaccine; safety effectiveness ... See more keywords
Real-world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance
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DOI: 10.1007/s10147-022-02155-3
Abstract: This all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC). This multicenter, open-label, non-interventional, observational PMS study (registered from August… read more here.
Keywords: safety effectiveness; post marketing; marketing surveillance; real world ... See more keywords
Safety and effectiveness of long-term use of darbepoetin alfa in non-dialysis patients with chronic kidney disease: a post-marketing surveillance study in Japan
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DOI: 10.1007/s10157-018-1632-9
Abstract: BackgroundThis post-marketing surveillance (PMS) study evaluated the safety and effectiveness of long-term darbepoetin alfa (darbepoetin) for the treatment of renal anemia in Japanese non-dialysis chronic kidney disease patients.MethodsPatients were treated with darbepoetin and followed up… read more here.
Keywords: long term; cardiovascular related; safety; safety effectiveness ... See more keywords
Safety and effectiveness of eribulin in Japanese patients with locally advanced or metastatic breast cancer: a post-marketing observational study
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DOI: 10.1007/s10637-017-0486-4
Abstract: SummaryBackground This large-scale study was conducted to evaluate the safety and effectiveness of eribulin for the treatment of inoperable or recurrent breast cancer in real-world settings in Japan. Methods Between July and December 2011, eligible… read more here.
Keywords: breast cancer; safety; effectiveness; safety effectiveness ... See more keywords
Safety and Effectiveness of Lenvatinib in 594 Patients with Unresectable Thyroid Cancer in an All-Case Post-Marketing Observational Study in Japan
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DOI: 10.1007/s12325-020-01433-8
Abstract: Lenvatinib is approved in Japan for treating patients with all histological subtypes of unresectable thyroid cancer, including differentiated thyroid cancer (DTC), medullary thyroid cancer (MTC), and anaplastic thyroid cancer (ATC). However, safety and effectiveness data… read more here.
Keywords: unresectable thyroid; safety effectiveness; thyroid cancer; patients unresectable ... See more keywords
Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study
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DOI: 10.1007/s13300-019-00723-x
Abstract: Introduction Clinical trials of linagliptin in Japanese patients conducted to date have had limited observational periods; therefore, there is a need for additional longer-term real-world data. The aim of this study was to investigate the… read more here.
Keywords: patients type; safety; safety effectiveness; japanese patients ... See more keywords
Long-Term Safety and Effectiveness of Adalimumab for Moderate to Severe Psoriasis: Results from 7-Year Interim Analysis of the ESPRIT Registry
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DOI: 10.1007/s13555-017-0198-x
Abstract: IntroductionESPRIT (NCT00799877) is an ongoing 10-year international prospective observational registry evaluating the long-term safety and effectiveness of originator adalimumab in routine clinical practice for adult patients with chronic plaque psoriasis. Herein, we report the long-term… read more here.
Keywords: long term; safety; safety effectiveness; term safety ... See more keywords
Real-world safety and effectiveness of insulin glargine 300 U/mL in participants with type 2 diabetes who fast during Ramadan: the observational ORION study.
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DOI: 10.1016/j.diabres.2020.108189
Abstract: AIMS ORION evaluated the safety and effectiveness of Gla-300 in insulin-treated people with T2DM before, during and after Ramadan, in a real-world setting. METHODS This prospective, observational study across 11 countries included participants with T2DM… read more here.
Keywords: insulin; gla 300; real world; safety effectiveness ... See more keywords
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study
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DOI: 10.1016/j.esxm.2020.100296
Abstract: Introduction Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce. Aim The aim of this… read more here.
Keywords: safety; dapoxetine demand; study; safety effectiveness ... See more keywords