Data and Safety Monitoring Board evaluation and management of a renal adverse event signal in TOPCAT

Author:

Bristow Michael R.1,Sharma Kavita2,Assmann Susan F.3,Linas Stuart4,Gersh Bernard J.5,Grady Christine6,Rice Madeline Murguia7,Singh Steven8,Boineau Robin9,McKinlay Sonja M.3,Greenberg Barry H.10

Affiliation:

1. Cardiovascular Institute; University of Colorado; Boulder and Aurora CO USA

2. Division of Cardiology, Department of Medicine; The Johns Hopkins Hospital; Baltimore MD USA

3. New England Research Institutes Clinical Trial Coordinating Center; Watertown MA USA

4. University of Colorado Department of Medicine; Division of Nephrology, Denver Health; Denver CO USA

5. Division of Cardiovascular Diseases, Mayo Clinic College of Medicine; Rochester MN USA

6. Department of Bioethics; National Institutes of Health Clinical Center; Bethesda MD USA

7. George Washington University Biostatistics Center; Washington DC USA

8. Washington VA Medical Center; Washington DC USA

9. Office of Clinical and Regulatory Affairs, National Center for Complementary and Integrative Health; National Institutes of Health; Bethesda MD USA

10. UC San Diego Medical Center; La Jolla CA USA

Funder

National Institutes of Health, NHLBI, Bethesda, MD

National Heart, Lung, and Blood Institute

Publisher

Wiley

Subject

Cardiology and Cardiovascular Medicine

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