VAYHIT3 trial design1
*Long-term safety monitoring includes only the collection of adverse events (AEs) and serious adverse events (SAEs) potentially related to B-cell depletion or assessed by the investigator as related to auxiliary medicinal products (AMPs) and SAEs assessed by the investigator as possibly related to ianalumab. If a different B cell-depleting therapy starts, AEs and SAEs assessed by the investigator as related to AMPs and SAEs assessed by the investigator as possibly related to ianalumab will be collected.
†Efficacy monitoring will end if, after Week 25 Day 1, the patient’s platelet count is less than 30 g/L, the patient starts a new line of immune thrombocytopenia therapy (ITC), or the patient requires a rescue treatment.
‡The study will end once all patients have completed 24 months of safety follow-up since their last dose of ianalumab or have been discontinued from the study earlier.
