Validation of safety outcomes in routinely collected data: Lessons learned from a multinational postapproval safety study

Affiliations

• ¹ Global Medical Epidemiology, Pfizer Inc., New York, New York, USA.
• ² Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, California, USA.
• ³ Centre for Pharmacoepidemiology, Karolinska Institutet, Karolinska University Hospital SE, Stockholm, Sweden.
• ⁴ Department of Research, Cancer Registry of Norway, Oslo, Norway.
• ⁵ Safety Surveillance Research, Pfizer Inc., New York, New York, USA.
• ⁶ Optum Inc., Boston, Massachusetts, USA.
• ⁷ Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, USA.
• ⁸ PHARMO Institute for Drug Outcomes Research, Utrecht, the Netherlands.
• ⁹ EPID Research, Espoo, Finland.
• ¹⁰ Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus N, Denmark.
• ¹¹ Department of Respiratory Diseases and Allergology, Aarhus University Hospital, Aarhus N, Denmark.
• ¹² Department of Medicine, Little Belt Hospital, Vejle, Denmark.
• ¹³ Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.