Teriparatide Did Not Increase Adult Osteosarcoma Incidence in a 15‐Year US Postmarketing Surveillance Study [PDF]
J Bone Miner Res, 2020 The Osteosarcoma Surveillance Study was initiated in the United States in 2003 to monitor for a potential association between the osteoporosis treatment teriparatide and osteosarcoma.
A. Gilsenan +5 more
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Safety and effectiveness of edoxaban in Japanese patients with nonvalvular atrial fibrillation: Final report of a two‐year postmarketing surveillance study (ETNA‐AF‐Japan) [PDF]
J Arrhythm, 2021 Direct oral anticoagulants (DOACs) are the recommended first‐line therapy for ischemic stroke prevention in patients with nonvalvular atrial fibrillation (NVAF).
T. Yamashita +3 more
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Real‐world safety and efficacy data of ipilimumab in Japanese radically unresectable malignant melanoma patients: A postmarketing surveillance [PDF]
J Dermatol, 2020 Treatment with immune checkpoint inhibitors has improved prognosis among patients with cutaneous melanoma, but there are still unmet medical needs in Japan, especially for mucosal melanoma and acral lentiginous melanoma (ALM) subtypes.
N. Yamazaki +7 more
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Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance [PDF]
Life (Basel), 2020 There are several different proposed data mining methods for the postmarketing surveillance of drug safety. Adverse events are often classified into a hierarchical structure. Our objective was to compare the performance of several of these different data
Goeun Park, Heesun Jung, S. Heo, I. Jung
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Enhancing postmarketing surveillance: continuing challenges [PDF]
British Journal of Clinical Pharmacology, 2015 In this issue, Zeitoun and colleagues 1 examined whether any relationship existed between the speed of European Medicines Agency (EMA) regulatory review of 161 medicines between 2001 and 2010 and reported postmarket safety events; they found no relevant correlation.
Dustin D. French +2 more
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ICD Leads and Postmarketing Surveillance [PDF]
New England Journal of Medicine, 2012 To the Editor: Product quality is our highest priority at St. Jude Medical (SJM). To ensure accuracy and address misperceptions, we are providing responses to assertions in the Perspective article by Hauser in this issue of the Journal.1 Assertion: Recommendations for following patients with Riata silicone-only leads for implantable cardioverter ...
Mark D. Carlson
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Postmarketing Surveillance of Pregnancy Outcomes With Dolutegravir Use [PDF]
J Acquir Immune Defic Syndr, 2019 individuals. JAIDS. 2019;82:314–320. 2. Hyle EP, Scott JA, Sax PE, et al. Clinical impact and cost-effectiveness of genotype testing at HIV diagnosis in the United States. Clin Infect Dis. 2019 [epub ahead of print]. 3. Nakagawa F, Miners A, Smith CJ, et
Melissa Crawford +9 more
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The Importance of Registries in the Postmarketing Surveillance of Surgical Meshes [PDF]
Ann Surg, 2017 Objective: To assess the role of registries in the postmarketing surveillance of surgical meshes. Background: To date, surgical meshes are classified as group II medical devices.
F. Köckerling +6 more
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Safety and efficacy of infliximab in the treatment of refractory uveoretinitis in Behçet’s disease: a large-scale, long-term postmarketing surveillance in Japan [PDF]
Arthritis Res Ther, 2019 BackgroundInfliximab, an anti-tumor necrosis factor-alpha antibody, has been reported to have excellent efficacy for refractory uveoretinitis in Behçet’s disease (RUBD), and was approved for this indication in Japan. However, the long-term safety profile
S. Ohno +4 more
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