title: 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.
authors.affiliation: 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.
authors.forename: Ilke
authors.initials: I
authors.lastname: Sipahi
authors.affiliation: Department of Cardiology, Acibadem University Medical School, Istanbul, Turkey.
authors.forename: Seden
authors.initials: S
authors.lastname: Celik
authors.affiliation: Department of Internal Medicine, Acibadem University Medical School, Istanbul, Turkey.
authors.forename: Nurdan
authors.initials: N
authors.lastname: Tozun
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects; D000991:Antithrombins / Q000009:adverse effects*; D001562:Benzimidazoles / Q000009:adverse effects*; D000069604:Dabigatran; D062313:Databases, Pharmaceutical; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced*; D006801:Humans; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D014481:United States; D014486:United States Food and Drug Administration; D014859:Warfarin / Q000009:adverse effects; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran