An Active Hemovigilance Program Provides Safety Data for Transfusing INTERCEPT™ Platelet and Plasma Components in Routine Clinical Practice

primary outcome measure was the incidence of acute transfusion reactions (ATR) following transfusion of I-PLA or I-PLT components. An ATR was defined as any AE possibly related, probably related, or related to the INTERCEPT transfusion. A serious adverse reaction (SAR) was defined as an SAE possibly related, probably related, or related to the INTERCEPT transfusion. The definition of any SAE (Grade 2-4 events ) was consistent with international regulatory guidance: outcomes that were fatal, life-threatening, required or prolonged hospitalization, resulted in congenital anomaly or birth defect, resulted in persistent or significant disability, or other important medical conditions. The INTERCEPT treatment system is approved to replace use of gamma irradiation, CMV testing, and bacterial detection.