Comparing time to adverse drug reaction signals in a spontaneous reporting database and a claims database: a case study of rofecoxib-induced myocardial infarction and rosiglitazone-induced heart failure signals in Australia.

摘要

This case study highlights that a post-marketing quantitative method utilising administrative claims data can be a complementary tool to traditional quantitative methods employed in spontaneous reports that may help to verify safety signals detected in spontaneous reporting data.