{"analyses":[{"ciLowerLimit":"-47.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.9","groupIds":["OG000","OG001"],"nonInferiorityComment":"Difference and 95% CI: difference of 2 Kaplan-Meier OS-1y rates and corresponding Greenwood standard errors.","nonInferiorityType":"OTHER","pValue":"0.0352","pValueComment":"One-sided P value","paramType":"Difference in Percentage","paramValue":"-22.9","statisticalMethod":"Kaplan Meier Method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.5","upperLimit":"67.0","value":"49.2"},{"groupId":"OG001","lowerLimit":"54.2","upperLimit":"83.9","value":"72.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"description":"OS-1y was defined as the time from the date of randomization to the date of death from any cause assessed up to 1 year. OS was calculated 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 12 or 1 Year","title":"Percentage of Participants With Overall Survival at 1 Year or Month 12 (OS-1y)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}