A comparison of results of the US food and drug administration's mini-sentinel program with randomized clinical trials: the case of gastrointestinal tract bleeding with dabigatran.

Ilke Sipahi, Seden Celik, Nurdan Tozun

Journal: JAMA internal medicine 2014;174(1):150-1

PMID: 24247291

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Abstract

Address: Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey2Harrington Heart and Vascular Institute, University Hospitals Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.; Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey.; Department of Internal Medicine, Acibadem University Medical School, Istanbul, Turkey.

DOI: 10.1001/jamainternmed.2013.12217

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MeSH Terms: Anticoagulants, Antithrombins, Benzimidazoles, Dabigatran, Databases, Pharmaceutical, Gastrointestinal Hemorrhage, Humans, Product Surveillance, Postmarketing, Randomized Controlled Trials as Topic, United States, United States Food and Drug Administration, Warfarin, beta-Alanine