Interim Analysis
VTE
ADVERSE EVENT
No interim analysis was planned. However, due to concerns raised from 1 ethics committee regarding a serious adverse event, an independent DSMB was assembled, and an interim analysis was performed. After the second interim analysis (December 2020), the DSMB recommended stopping patient enrollment, as the stopping rule had been met for the primary outcome of the CRISTAL trial (a between-group difference for symptomatic VTE within 90 days at 