{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"5.0","value":"3.7"},{"groupId":"OG001","lowerLimit":"0.6","upperLimit":"10.6","value":"6.3"},{"groupId":"OG002","lowerLimit":"1.4","upperLimit":"11.3","value":"5.5"},{"comment":"95% CI could not be estimated as insufficient number of participants were available for analysis.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"5.5"},{"groupId":"OG004","lowerLimit":"1.8","upperLimit":"5.4","value":"3.0"},{"comment":"Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.","groupId":"OG005","lowerLimit":"2.1","upperLimit":"NA","value":"7.1"},{"groupId":"OG006","lowerLimit":"11.1","upperLimit":"16.1","value":"12.0"},{"comment":"Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.","groupId":"OG007","lowerLimit":"4.2","upperLimit":"NA","value":"6.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"15"},{"groupId":"OG007","value":"20"}],"units":"Participants"}],"description":"TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants (age group 2 to \\<6 years \\[following completion of run-in period\\] and 6 to \\<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\\^2 (per BSA, 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 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.","id":"OG000","title":"Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2"},{"description":"Participants (age group 2 to \\<6 years \\[following completion of run-in period\\] and 6 to \\<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\\^2 (per BSA, 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 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 participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.","id":"OG001","title":"Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2"},{"description":"Participants (of age group 6 to \\<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\\^2 (administered per BSA, 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 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 in Cohort 1=28 days.","id":"OG002","title":"Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2"},{"description":"Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\\^2 (administered 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 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 in Cohort 2A=28 days.","id":"OG003","title":"Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2"},{"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 in Cohort 2B=28 days.","id":"OG004","title":"Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2"},{"description":"Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\\^2 (20% lower than the RD from Cohort 1; administered 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 in Cohort 3A=21 days.","id":"OG005","title":"Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/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 in Cohort 3A=21 days.","id":"OG006","title":"Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/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 in Cohort 3B=21 days.","id":"OG007","title":"Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2"}],"paramType":"MEDIAN","populationDescription":"Full analysis set included all enrolled participants who did not fail study screening.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug until PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)","title":"Cohorts 1, 2A, 2B, 3A and 3B: Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"months"}