{"analyses":[{"groupDescription":"C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"=0.20359","statisticalMethod":"Wilcoxon Rank-Sum Test"},{"groupDescription":"C2D1: FGF 19 (PFS-4, Yes) vs. C2D1: FGF 19 (PFS-4, No)","groupIds":["OG001"],"nonInferiorityType":"OTHER","pValue":"=0.50068","statisticalMethod":"Wilcoxon Rank-Sum Test"},{"groupDescription":"C3D1: FGF 19 (PFS-4, Yes) vs. C3D1: FGF 19 (PFS-4, No)","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"=0.05512","statisticalMethod":"Wilcoxon Rank-Sum Test"},{"groupDescription":"C4D1: FGF 19 (PFS-4, Yes) vs. C4D1: FGF 19 (PFS-4, No)","groupIds":["OG001"],"nonInferiorityType":"OTHER","pValue":"=0.50382","statisticalMethod":"Wilcoxon Rank-Sum Test"},{"groupDescription":"C2D1: FGF 21 (PFS-4, Yes) vs. C2D1: FGF 21 (PFS-4, No)","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"=0.04760","statisticalMethod":"Wilcoxon Rank-Sum 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(PFS-4, Yes) vs. C3D1: VEGF (PFS-4, No)","groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"=1.00000","statisticalMethod":"Wilcoxon Rank-Sum Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"110.78","value":"48.7"},{"groupId":"OG001","spread":"211.86","value":"172.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C2D1: FGF 19 (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"139.19","value":"109.9"},{"groupId":"OG001","spread":"203.30","value":"78.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"C2D1: FGF 19 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"130.42","value":"47.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: FGF 19 (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"180.71","value":"194.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: FGF 19 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"204.94","value":"237.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C4D1: FGF 19 (PFS-4, Yes)"},{"categories":[{"measurements":[{"comment":"Standard deviation could not be estimated as insufficient number of participants were available for analysis.","groupId":"OG001","spread":"NA","value":"91.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"C4D1: FGF 19 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"68.95","value":"-14.9"},{"groupId":"OG001","spread":"138.90","value":"70.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C2D1: FGF 21 (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"203.81","value":"134.3"},{"groupId":"OG001","spread":"48.64","value":"7.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"C2D1: FGF 21 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"125.51","value":"55.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: FGF 21 (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"88.92","value":"17.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: FGF 21 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"323.34","value":"256.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C4D1: FGF 21 (PFS-4, Yes)"},{"categories":[{"measurements":[{"comment":"Standard deviation could not be estimated as insufficient number of participants were available for analysis.","groupId":"OG001","spread":"NA","value":"-1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}],"units":"Participants"}],"title":"C4D1: FGF 21 (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"309.01","value":"119.9"},{"groupId":"OG001","spread":"105.60","value":"87.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C2D1: VEGF (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"212.18","value":"124.2"},{"groupId":"OG001","spread":"92.53","value":"95.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"title":"C2D1: VEGF (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"153.50","value":"64.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: VEGF (PFS-4, Yes)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"69.67","value":"23.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C3D1: VEGF (PFS-4, No)"},{"categories":[{"measurements":[{"groupId":"OG001","spread":"97.85","value":"84.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"}],"units":"Participants"}],"title":"C4D1: VEGF (PFS-4, Yes)"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}],"units":"Participants"}],"title":"C4D1: VEGF (PFS-4, No)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"description":"Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per \"PFS-4, Yes\" and \"PFS-4, No\" have been reported. As per assessment of investigator based on RECIST v1.1, \"PFS-4, Yes\"= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, \"PFS-4, No\"=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose.","dispersionType":"Standard Deviation","groups":[{"description":"Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle=28 days.","id":"OG000","title":"Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2"},{"description":"Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\\^2/day intravenously and etoposide 100 mg/m\\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle=21 days.","id":"OG001","title":"Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2"}],"paramType":"MEAN","populationDescription":"PFS-4 evaluable set: all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose or received anticancer treatment within 4 months after first dose. \"N\": participants evaluable for this measure. \"n\": participants who were evaluable for this measure for specific rows.","reportingStatus":"POSTED","timeFrame":"Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)","title":"Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level","type":"SECONDARY","unitOfMeasure":"percent change"}