{"analyses":[{"ciLowerLimit":"1.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.16","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0001","paramType":"Odds Ratio (OR)","paramValue":"2.14","statisticalComment":"Adjusted for stratification factors: geographic region, time-to-progression from the start of first-line therapy and disease measurability.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"23.3","upperLimit":"33.0","value":"27.9"},{"groupId":"OG001","lowerLimit":"12.6","upperLimit":"20.4","value":"16.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"330"},{"groupId":"OG001","value":"335"}],"units":"Participants"}],"description":"ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\\*100.","dispersionType":"95% Confidence Interval","groups":[{"description":"8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.","id":"OG000","title":"Ramucirumab (IMC-1211B) Plus Paclitaxel"},{"description":"Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.","id":"OG001","title":"Placebo Plus Paclitaxel"}],"paramType":"NUMBER","populationDescription":"All participants according to the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Randomization up to 22.2 months","title":"Percentage of Participants With CR or PR (Objective Response Rate [ORR])","type":"SECONDARY","unitOfMeasure":"percentage of participants"}