Mini-sentinel methods framework for assessment of signal refinement positive results

Author Affiliations: 1. Marshfield Epidemiology Research Center, Marshfield Clinic Research Foundation, Marshfield WI. 2. Institute for Health Research, Kaiser Permanente Colorado, Denver CO. 3. University of Colorado Skaggs School of Pharmacy and Pharmaceutical Science, Aurora, CO. 4. Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston MA. 5. Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. 6. Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. 7. Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD