Assessing the Performance of Major Congenital Malformations as a Composite Outcome in Signal Detection and Evaluation

This poster describes a project that assessed the performance in detecting potential safety signals for selected/specific major congenital malformations (MCM) by utilizing two approaches: targeted analysis that uses a composite MCM as an outcome and untargeted analysis that uses tree-based scan statistics (TBSS). It was presented at the 2026 ISPE Annual Meeting.