{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"59.0","upperLimit":"70.5","value":"64.8"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"3.6","value":"1.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"261"},{"groupId":"OG001","value":"131"}],"units":"Participants"}],"description":"ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by blinded IIR using RECIST 1.1 for target lesions and assessed by magnetic resonance imaging/computed tomography (MRI/CT) scans (for double blind treatment period i.e. Randomization Phase). CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.","id":"OG000","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":"OG001","title":"Randomization Phase: Placebo"}],"paramType":"NUMBER","populationDescription":"The full analysis set (Intent-to-Treat Analysis Set) included all randomized participants.","reportingStatus":"POSTED","timeFrame":"Date of randomization to the date of disease progression or death (whichever occurred first), assessed up to data cutoff date (15 Nov 2013) or up to approximately 2.5 years","title":"Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}