{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"}],"units":"Participants"}],"description":"The MTD was defined as the maximum tolerated dose observed after the evaluation of dose limiting toxicity (DLT) in Cycle 1 with 6 participants. If it was judged that the dose was not tolerated and DLT was confirmed in only 3 participants in the lower dose cohort, 3 other participants were to be added and tolerability was evaluated with 6 participants in total. The RD was to be comprehensively determined based on the MTD and safety data. Participants not evaluable for DLT were defined as participants found to be ineligible or in whom DLT evaluation was impossible due to premature termination for reasons other than toxicities in the judgement of the Sponsor, among those who had received at least one dose of the investigational drug after enrollment.","groups":[{"description":"Denileukin diftitox was intravenously (IV) infused for 60 minutes (±10 minutes) daily from Day 1 through Day 5 of each Cycle (1 cycle = 3 weeks).","id":"OG000","title":"Denileukin Diftitox"}],"paramType":"NUMBER","populationDescription":"DLT evaluation analysis set included all participants after excluding, from the Safety Analysis Set, participants who were non-evaluable for DLT.","reportingStatus":"POSTED","timeFrame":"For each dose, first dose of study drug (Cycle 1 Day 1) to end of Cycle 1 (Day 21) (1 cycle = 3 weeks)","title":"Maximum Tolerated Dose (MTD) and Recommended Dose (RD)","type":"PRIMARY","unitOfMeasure":"ug/kg/day"}