{"classes":[{"categories":[{"measurements":[{"comment":"Number and 95% confidence interval data could not be estimated because all participants had an event or were censored before Month 12.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"1.1","upperLimit":"44.5","value":"14.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.","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":"Month 12 or 1 Year","title":"Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}