{"groups":[{"description":"Participants received lenvatinib 24 milligram (mg), hard capsule, orally, once daily, until documentation of disease progression (confirmed by Investigator-Initiated Research \\[IIR\\]), development of unacceptable toxicity, or withdrawal of consent.","id":"FG000","title":"Randomization Phase: Lenvatinib 24 mg"},{"description":"Participants received matching-placebo, hard capsule, orally, once daily until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.","id":"FG001","title":"Randomization Phase: Placebo"},{"description":"Participants received lenvatinib 24 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. OOL refers to Optional Open-Label.","id":"FG002","title":"OOL, Treatment Period: Lenvatinib 24 mg"},{"description":"Participants received lenvatinib 20 mg, hard capsule, orally, once daily in Treatment Period. Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib.","id":"FG003","title":"OOL, Treatment Period: Lenvatinib 20 mg"}],"periods":[{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"261"},{"groupId":"FG001","numSubjects":"131"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"261"},{"groupId":"FG001","numSubjects":"131"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomization Phase"},{"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Participants from randomization phase were re-randomized to OOL, treatment period.","groupId":"FG002","numSubjects":"85"},{"comment":"Participants from randomization phase were re-randomized to OOL, treatment period.","groupId":"FG003","numSubjects":"30"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"85"},{"groupId":"FG003","numSubjects":"30"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"OOL Lenvatinib Treatment Period"}],"preAssignmentDetails":"A total of 612 participants were screened for entry into the study. Of these 612 participants, 220 participants were screening failures and 392 participants were randomly assigned to receive either lenvatinib or placebo in a 2:1 ratio.","recruitmentDetails":"Participants took part in the study at 117 investigative sites in Europe, North America, Asia Pacific, Japan, and Latin America from 17 March 2011 to 19 March 2019."}