Details
Prospective routine observational monitoring assessment of selected safety outcomes (acute myocardial infarction and stroke) in adults who are new users of mirabegron, with oxybutynin as the comparator. This assessment will utilize Mini-Sentinel’s Prospective Routine Observational Monitoring Programming Tools (PROMPT) surveillance system. Click here for more information about PROMPT.
The Mini-Sentinel Operations Center posted this final draft surveillance plan for public comment from May 1, 2014 through May 15, 2014. The public comment period is now closed. Revised versions were approved for implementation by FDA on June 11, 2014, and September 19, 2016. A log of changes is included in the revised surveillance plan (v3.0).
Additional Information
Contributors
Charles E. Leonard PharmD, MSCE; Sean Hennessy PharmD, PhD; Center for Pharmacoepidemiology Research and Training, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA
Marsha Reichman PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Darren Toh ScD; Martin Kulldorff PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA
Jennifer C. Nelson PhD; Group Health Research Institute, Seattle, WA
Joshua J. Gagne PharmD, ScD; Shirley V. Wang PhD, ScM; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA
Rita P. Ouellet-Hellstrom PhD, MPH; David G. Moeny RPh, MPH; Katrina A. Mott MHS; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD
Kunthel By PhD, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA, Silver Spring, MD