{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.79","groupDescription":"900 patients were planned to be enrolled in order to randomize 558 pts to maintenance therapy. This trial was powered for the primary endpoint, PFS (90% power, assuming 238 events with 52% censoring and a PFS Hazard Ratio (HR)=0.65, alpha=0.05). This trial was also powered for a secondary endpoint, OS (93% power, assuming 390 events with 30% censoring and an OS HR=0.70). Alpha was controlled for both a preliminary analysis (alpha=0.0001) and final analysis of OS (alpha=0.0499).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.00006","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.15","upperLimit":"4.57","value":"4.11"},{"groupId":"OG001","lowerLimit":"2.60","upperLimit":"3.12","value":"2.83"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"359"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care","id":"OG000","title":"Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed"},{"description":"pemetrexed + cisplatin followed by placebo plus best supportive care","id":"OG001","title":"Pemetrexed + Cisplatin Followed by Placebo"}],"paramType":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)","title":"Investigator-assessed Objective Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}