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. 2016 Jun 2;39:873–881. doi: 10.1007/s40264-016-0433-x
Detection of drug safety signals in children, who represent a heterogeneous population, where age may be a confounder or effect modifier, is an area in which only limited research has been carried out.
The signal detection algorithms (SDAs) showed good performance on pediatric data and can be utilized for pediatric signal detection.
Age adjustment did not improve the performance of the SDAs.
Age stratification showed that some signals may be detected only in specific pediatric age groups. For routine surveillance, checking for effect modification across age strata may generate useful information.