Antithymocyte-globulin/Arsenic-trioxide/Busulfan/Fludarabine/Gilteritinib/Tretinoin
Off-label use followed by lack of efficacy and QTc prolongation-
Serious
An event is determined to be serious (based on the ICH definition) when the patient outcome is:
death
life-threatening
hospitalisation
disability
congenital anomaly
other medically important event