{"analyses":[{"ciLowerLimit":"5.4","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"41.7","estimateComment":"Overall response percent for Pemetrexed/Carboplatin arm (percent of eligible, treated patients with complete or partial response)","groupDescription":"The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Overall Response Percent","paramValue":"18.8"},{"ciLowerLimit":"0.0","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"20.6","estimateComment":"Overall response percent for Pemetrexed/Gemcitabine arm (percent of eligible, treated patients with complete or partial response)","groupDescription":"The treatment was to be considered promising if a true response rate of 40% or higher was observed, whereas a rate of 15% or less would not be of interest. 3 or more responses were required to expand accrual to a second stage. This expansion did not occur.","groupIds":["OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Overall Response Percent","paramValue":"0.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"6"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"}]}],"title":"Progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Unevaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"}],"units":"Participants"}],"description":"Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.","groups":[{"description":"Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.","id":"OG000","title":"Pemetrexed/Carboplatin"},{"description":"Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.","id":"OG001","title":"Pemetrexed/Gemcitabine"}],"paramType":"NUMBER","populationDescription":"The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.","reportingStatus":"POSTED","timeFrame":"Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression","title":"Best Overall Response by RECIST Criteria (Version 1.0)","type":"PRIMARY","unitOfMeasure":"eligible, treated participants"}