{"analyses":[{"ciLowerLimit":"0.743","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.975","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0201","paramType":"Hazard Ratio (HR)","paramValue":"0.851","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.6","upperLimit":"6.0","value":"5.7"},{"groupId":"OG001","lowerLimit":"4.8","upperLimit":"5.6","value":"5.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"545"},{"groupId":"OG001","value":"548"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization until the first radiographic documentation of objective measured progressive disease as defined by RECIST (Version 1.0), or death from any cause. Progressive Disease (PD) was defined as having at least a 20% increase in the sum of the longest diameter of target lesions. Participants who die without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. If no baseline or postbaseline radiologic assessment was available, the participants were censored at the date of randomization. If death or PD occurs after two or more consecutive missing radiographic visits, censoring occurred at the date of the last radiographic visit prior to the missed visits.","dispersionType":"95% Confidence Interval","groups":[{"description":"Necitumumab + Gemcitabine + Cisplatin\n\nNecitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.\n\nContinues until progressive disease, toxicity, noncompliance, or withdrawal.\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.","id":"OG000","title":"Necitumumab + Gemcitabine + Cisplatin"},{"description":"Gemcitabine + Cisplatin\n\nGemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.\n\nContinues for a maximum of six cycles.\n\nCisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.\n\nContinues for a maximum of six cycles.","id":"OG001","title":"Gemcitabine + Cisplatin"}],"paramType":"MEDIAN","populationDescription":"All randomized participants. Censored participants: Necitumumab + Gemcitabine + Cisplatin = 114, Gemcitabine + Cisplatin = 131","reportingStatus":"POSTED","timeFrame":"Randomization to Measured Progressive Disease or Death from Any Cause (Up to 31 Months)","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}