Lenalidomide
Off-label-use in myelodysplastic syndromes leading to progression to acute myeloid leukaemia, second primary malignancies, neutropenia, thrombocytopenia and death: 523 case reports-
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