Post-marketing safety surveillance of Ado-Trastuzumab Emtansine: a real-world data retrospective cohort study using disproportionality analysis

Background Ado-trastuzumab emtansine (T-DM1) is prescribed for HER2-positive, metastatic breast cancer or early breast cancer after neoadjuvant therapy. Although several adverse events (AEs) have been reported, there remains a need for comprehensive evaluation of its safety profile.