Evaluating rivaroxaban for nonvalvular atrial fibrillation - Regulatory considerations

New England Journal of Medicine

Volumn 365, Issue 17, 2011, Pages 1557-1559

  Fleming, Thomas R ^a   Emerson, Scott S ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; PLACEBO; RIVAROXABAN; WARFARIN;

BLEEDING; DRUG APPROVAL; DRUG EFFICACY; DRUG HALF LIFE; DRUG MARKETING; DRUG SCREENING; EMBOLISM; FOOD AND DRUG ADMINISTRATION; HEART ATRIUM FIBRILLATION; HUMAN; PRIORITY JOURNAL; SHORT SURVEY; STROKE;

EID: 80054896035     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1110639     Document Type: Short Survey

References (4)

1. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365:883-91.
2. Fleming TR, Odem-Davis K, Rothmann MD, Li Shen Y. Some issues of integral importance in the design and conduct of noninferiority trials. Clin Trials 2011;8:432-9.
3. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361: 1139-51. [Erratum, N Engl J Med 2010;363: 1877.]
4. Food and Drug Administration. Statement regarding the demonstration of effectiveness of human drug products and devices. Fed Regist 1995;60:39180-1.