{"classes":[{"categories":[{"measurements":[{"comment":"95% CI could not be estimated as insufficient number of participants were available for analysis.","groupId":"OG003","lowerLimit":"NA","upperLimit":"NA","value":"1.9"},{"comment":"95% CI could not be estimated as insufficient number of participants were available for analysis.","groupId":"OG004","lowerLimit":"NA","upperLimit":"NA","value":"4.6"},{"comment":"Median and 95% CI could not be estimated because all participants were censored from the analysis.","groupId":"OG005","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Median and 95% CI could not be estimated because all participants were censored from the analysis.","groupId":"OG007","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"3"}],"units":"Participants"}],"description":"DOR was defined as time in months from the first documentation confirmed CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \\<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. 95% CI for the 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. Here \"overall number of participants analyzed, N\" signifies participants who were evaluable for this measure. Here, \"N\" for Cohort 1 (Lenvatinib 11, 14, 17 mg/m\\^2) and Cohort 3A (Lenvatinib 14 mg/m\\^2) is zero as there were no events of CR or PR in these arms.","reportingStatus":"POSTED","timeFrame":"First documentation of CR/PR until first documentation of 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: Duration of Response (DOR)","type":"SECONDARY","unitOfMeasure":"months"}