{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"214.01","value":"295.6"},{"groupId":"OG001","spread":"145.83","value":"134.8"},{"groupId":"OG002","spread":"81.40","value":"52.5"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"11.1"},{"groupId":"OG004","spread":"191.03","value":"177.4"},{"groupId":"OG005","spread":"131.54","value":"105.2"},{"groupId":"OG006","spread":"131.47","value":"111.4"},{"groupId":"OG007","spread":"197.66","value":"209.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"29"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"11"},{"groupId":"OG007","value":"20"}],"units":"Participants"}],"title":"Cycle 1 Day 1: 0.5-4 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hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.01","value":"46.9"},{"groupId":"OG001","spread":"29.19","value":"59.1"},{"groupId":"OG002","spread":"66.10","value":"96.9"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"56.2"},{"groupId":"OG004","spread":"53.78","value":"67.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"29"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"163.37","value":"133.4"},{"groupId":"OG001","spread":"204.61","value":"226.6"},{"groupId":"OG002","spread":"190.22","value":"191.8"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"124"},{"groupId":"OG004","spread":"157.67","value":"168.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"28"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15: 0.5-4 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"157.15","value":"351.8"},{"groupId":"OG001","spread":"121.21","value":"375.8"},{"groupId":"OG002","spread":"221.47","value":"413.0"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"247"},{"groupId":"OG004","spread":"138.87","value":"322.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"29"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 15: 6-10 hours"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.58","value":"58.1"},{"groupId":"OG001","spread":"60.61","value":"61.6"},{"groupId":"OG002","spread":"77.08","value":"97.9"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"59.8"},{"groupId":"OG004","spread":"62.50","value":"66.8"},{"groupId":"OG005","spread":"44.23","value":"51.7"},{"groupId":"OG006","spread":"63.25","value":"76.1"},{"groupId":"OG007","spread":"65.10","value":"50.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"27"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"17"}],"units":"Participants"}],"title":"Cycle 2 Day 1: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"360.71","value":"502.4"},{"groupId":"OG001","spread":"229.29","value":"440.7"},{"groupId":"OG002","spread":"212.44","value":"339.2"},{"comment":"Standard deviation could not be calculated because only one participant was available for analysis.","groupId":"OG003","spread":"NA","value":"102"},{"groupId":"OG004","spread":"217.49","value":"382.4"},{"groupId":"OG005","spread":"134.66","value":"205.6"},{"groupId":"OG006","spread":"124.82","value":"237.4"},{"groupId":"OG007","spread":"135.73","value":"275.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"28"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"9"},{"groupId":"OG007","value":"18"}],"units":"Participants"}],"title":"Cycle 2 Day 1: 2-12 hours"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"11"},{"groupId":"OG006","value":"11"},{"groupId":"OG007","value":"20"}],"units":"Participants"}],"description":"Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days.","dispersionType":"Standard Deviation","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":"MEAN","populationDescription":"Pharmacokinetic (PK) Analysis Set included all participants who had received any study drug and had evaluable PK data. Here \"number analyzed, n\" signifies participants who were evaluable for this outcome measure at given time points.","reportingStatus":"POSTED","timeFrame":"Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose","title":"Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib","type":"SECONDARY","unitOfMeasure":"nanogram per milliliter (ng/mL)"}