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Description
Tree-based scan statistics detect safety signals by leveraging a hierarchical outcome tree and by controlling for multiplicity inherent in evaluating overlapping outcome groups. Baloxavir marboxil (BXM), FDA approved in 2018, is a first-in-class influenza-specific endonuclease inhibitor approved for acute uncomplicated influenza or post-exposure prophylaxis in adult and pediatric patients.
This poster compares incident outcomes in new users of BXM with oseltamivir (OTV), a first-line influenza treatment and prophylactic with a different mechanism of action and greater postmarketing exposure. It was presented at the 2024 ISPE Annual Meeting.