{"analyses":[{"ciLowerLimit":"-10.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"31.1","groupIds":["OG000","OG001"],"nonInferiorityComment":"Difference in PFS rates, and 2-sided 95% confidence intervals (CIs): CI and p-value constructed using the difference of the 2 Kaplan-Meier PFS rates (4 months) and the 2 corresponding Greenwood standard errors.","nonInferiorityType":"OTHER","pValue":"0.1683","pValueComment":"One-sided P value","paramType":"Difference in Percentage","paramValue":"10.2","statisticalMethod":"Kaplan-Meier Method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.3","upperLimit":"86.9","value":"76.3"},{"groupId":"OG001","lowerLimit":"47.7","upperLimit":"79.2","value":"66.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"PFS rate at 4 months as assessed by IIR was defined as the percentage of participants who were alive and without PD at 4 months from the 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. The PFS-4m was estimated using the 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 4","title":"Percentage of Participants With PFS at Month 4 (PFS-4m Rate) by IIR Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}