{"analyses":[{"ciLowerLimit":"0.86","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.45","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.3997","paramType":"Odds Ratio (OR)","paramValue":"1.12","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"27.4","upperLimit":"35.2","value":"31.2"},{"groupId":"OG001","lowerLimit":"25.2","upperLimit":"32.8","value":"28.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"545"},{"groupId":"OG001","value":"548"}],"units":"Participants"}],"description":"ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.0, CR was defined as the disappearance of all target and non-target lesions. PR defined as a \\>=30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \\* 100.","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":"NUMBER","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Baseline to Measured Progressive Disease (Up to 31 Months)","title":"Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) (Objective Response Rate [ORR])","type":"SECONDARY","unitOfMeasure":"percentage of participants"}