{"analyses":[{"ciLowerLimit":"-10.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.0","groupIds":["OG000","OG001"],"nonInferiorityComment":"Difference calculated as Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide minus Treatment Arm B: Ifosfamide + Etoposide. 2-sided 95% CI: Miettinen-Nurminen (Score) confidence limits, stratified by randomization stratification factor age (\\<18 and \\>=18 years).","nonInferiorityType":"OTHER","paramType":"Difference in Percentage","paramValue":"5.2"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.7","upperLimit":"29.8","value":"15.0"},{"groupId":"OG001","lowerLimit":"2.7","upperLimit":"23.1","value":"9.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"ORR by IIR was defined as the percentage of participants with best overall response of CR or PR determined using RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \\<10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. 95% CI of ORR was calculated using the method of Clopper and Pearson.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received lenvatinib 14 mg/m\\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\\^2/day, intravenously and etoposide 100 mg/m\\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.","id":"OG000","title":"Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide"},{"description":"Participants received ifosfamide 3000 mg/m\\^2/day, intravenously and etoposide 100 mg/m\\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.","id":"OG001","title":"Treatment Arm B: Ifosfamide + Etoposide"}],"paramType":"NUMBER","populationDescription":"FAS included all randomized participants regardless of the treatment actually received.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the date of the first documentation of CR or PR (up to 20.5 months)","title":"ORR by IIR Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}