Statement: the primary trial recorded 23 adverse events.
Primary_evidence: Adverse Events 1:   Total: 0/23 (0.00%)   LEFT VENTRICULAR SYSTOLIC DYSFUNCTION *0/23 (0.00%)   NAUSEA *0/23 (0.00%)   VOMITING *0/23 (0.00%)   BILIRUBIN (HYPERBILIRUBINEMIA) *0/23 (0.00%)   INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E *0/23 (0.00%)   NEUTROPHILS/GRANULOCYTES (ANC/AGC) *0/23 (0.00%)