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During the conduct of the pediatric studies (STARTS-1 and STARTS-2) [see Clinical Studies (14)], an imbalance in the number of deaths was noted: 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively

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Mechanisms of action Anti-CD38 antibodies exert their therapeutic effects via direct effector mechanisms on MM cells (i.e., CD38 enzymatic inhibition, direct induction of apoptosis) and through Fc-dependent immune mechanisms, including antibody-dependent cellular cytotoxicity (ADCC), complement-directed cytotoxicity (CDC), and antibody-directed cellular phagocytosis (ADCP) (Fig