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

    Basic Details
    Date
    Tuesday, November 13, 2018
    Type
    Publication
    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.

    Author(s)

    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

    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