Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis

Project Title Overall and Cause-Specific Mortality in the Sentinel System: A Power Analysis
Date
Tuesday, November 13, 2018
Location

Pharmacoepidemiol Drug Saf. 2018 Nov 13. DOI: 10.1002/pds.4692

Description

Mortality data within the Sentinel Death Tables remain generally uncharacterized. Assessment of mortality data within Sentinel will help inform its utility for medical product safety studies. This investigation found that all‐cause mortality appeared well powered for use as a safety outcome and cause‐specific mortality outcomes may be adequately powered in certain circumstances.

Corresponding Author

Richard S. Swain, FDA Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 22, Room 2409, Silver Spring, MD 20993. Email: richard.swain@fda.hhs.gov

Authors

Richard S. Swain, Lockwood G. Taylor, Tiffany S. Woodworth, Candace C. Fuller, Andrew B. Petrone, Talia J. Menzin, Nicole R. Haug, Sengwee Toh, Andrew D. Mosholder

Related Assessments
2017 ICPE Presentation: Feasibility Analysis of Mortality Outcomes in the Sentinel Distributed Database
Top Ten Causes of Death
Publication Type
Publication
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