Outcomes
Neuroblastoma, Tumor, pain
ADVERSE EVENTS, ADVERSE EVENT, NEUROBLASTOMA, TUMOR
The primary endpoint of the study was the objective response rate (ORR) 24 weeks after the end of cycle 5, defined as the proportion of patients with a complete or partial response based on the International Neuroblastoma Response Criteria (INRC) [Tumor assessments according to the INRC, including magnetic resonance imaging (MRI), computed tomography (CT) and Safety and tolerability assessments included changes in vital signs and clinical laboratory parameters, pain intensity assessment scores (0 [no pain] to 10 [unbearable pain] on a validated pain scale), and the need for, amount, and duration of intravenous morphine. In addition, adverse events were recorded and graded using the Common Terminology Criteria for Adverse Events, version 4.0.Pharmacokinetic assessments included determining dinutuximab beta serum concentrations in cycle 1 at baseline, the end of infusion, and on days 15, 22, 29, and 35 [