There is an increased risk of death due to infection and VOD after receiving BESPONSA; Low blood cell counts: Low blood cell counts and complications of low blood cell counts, including bleeding and infections, which may be severe, life-threatening, and fatal, have occurred with BESPONSA.. Hepatotoxicity, Including Hepatic VOD: Hepatotoxicity, including fatal and life-threatening VOD, occurred in 23/164 patients (14%) during or following treatment with BESPONSA or following subsequent HSCT. VOD was reported up to 56 days after the last dose during treatment or follow-up without an intervening HSCT. The median time from HSCT to onset of VOD was 15 days.. BESPONSA significantly increased the risk of VOD/SOS above that of standard chemotherapy regimens in this patient population. This risk was most marked in patients who underwent subsequent HSCT. This risk was most marked in patients who underwent subsequent HSCT.. In the Besponsa arm, among the 79 patients who proceeded to a subsequent HSCT, VOD was reported in 18/79 patients (23%), and among all 164 patients treated, VOD was reported in 5/164 patients (3%) during study therapy or in follow-up without an intervening HSCT.. . .