Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials

Author:

Fanaroff Alexander C.12,Clare Robert2,Pieper Karen S.2,Mahaffey Kenneth W.3,Melloni Chiara12,Green Jennifer B.24,Alexander John H.12,Jones W. Schuyler12,Harrison Robert W.12,Mehta Rajendra H.2,Povsic Thomas J.12,Moreira Humberto G.5,Al-Khatib Sana M.12,Roe Matthew T.12,Kong David F.12,Mathews Robin12,Tricoci Pierluigi6,Holman Rury R.7,Wallentin Lars8,Held Claes8,Califf Robert M.129,Alexander Karen P.12,Lopes Renato D.12

Affiliation:

1. Division of Cardiology (A.C.F., C.M., J.H.A., W.S.J., R.W.H., T.J.P., S.M.A-K., M.T.R., D.F.K., R.M., R.M.C., K.P.A., R.D.L.), Duke University School of Medicine, Durham, NC.

2. Duke Clinical Research Institute (A.C.F. R.C., K.S.P., C.M., J.B.G., J.H.A., W.S.J., R.W.H., R.H.M., T.J.P., S.M.A-K., M.T.R., D.F.K., R.M., R.M.C., K.P.A., R.D.L.), Duke University School of Medicine, Durham, NC.

3. Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).

4. Division of Endocrinology (J.B.G.), Duke University School of Medicine, Durham, NC.

5. Heart Institute (InCor), University of São Paulo Medical School, Brazil (H.G.M.).

6. CSL Behring, King of Prussia, PA, (P.T.).

7. Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, United Kingdom (R.R.H).

8. Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Institute, Uppsala University, Sweden (L.W., C.H.).

9. Verily Life Sciences, South San Francisco, CA (R.M.C.).

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference31 articles.

1. Hicks KA Hung H Mahaffey KW Mehran R Nissen SE Stockbridge NL Targum SL Temple R. Standardized definitions for cardiovascular and stroke end point events in clinical trials. Clinical Data Interchange Standards Consortium. https://www.cdisc.org/system/files/all/standard/Draft%20Definitions%20for%20CDISC%20August%2020%2C%202014.pdf. August 20 2014. Accessed October 2 2018.

2. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

3. FDA Briefing Document: Endocrine and Metabolic Drug Advisory Committee Meeting: June 28 2016. https://www.fda.gov/downloads/AdvisoryCommittees/UCM508422.pdf. 2016. Accessed October 2 2018.

4. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes

5. Effect of valsartan on the incidence of diabetes and cardiovascular events.;NAVIGATOR Study Group;N Engl J Med,2010

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