Time-to-onset in spontaneous reports: the possibility to detect the unexpected.

摘要

We read with great interest the paper entitled Using time-to-onset for detecting safety signals in spontaneous reports of adverse events following immunization: a proof of concept study by Van Holle et al. published in the June 2012 issue of this journal. The authors propose that safety signals in collections of spontaneous reports (in their case, adverse events following immunization) can be identified based on patterns of reported time-to-onset that deviate from the overall patterns of reported time-to-onset of that drug with other adverse drug reactions (ADRs) and of that ADR with other drugs.