{"analyses":[{"ciNumSides":"TWO_SIDED","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.6336","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.7","upperLimit":"16.6","value":"13.4"},{"groupId":"OG001","lowerLimit":"9.8","upperLimit":"15.6","value":"12.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"536"},{"groupId":"OG001","value":"536"}],"units":"Participants"}],"description":"The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 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 at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.","dispersionType":"95% Confidence Interval","groups":[{"description":"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nRamucirumab: 8 mg/kg administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"OG000","title":"Ramucirumab + FOLFIRI"},{"description":"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.\n\nPlacebo: Administered intravenously.\n\nIrinotecan: 180 mg/m\\^2 administered intravenously.\n\nFolinic Acid: 400 mg/m\\^2 administered intravenously.\n\n5-Fluorouracil: 400 mg/m\\^2 bolus immediately followed by 2400 mg/m\\^2 continuous infusion.","id":"OG001","title":"Placebo + FOLFIRI"}],"paramType":"NUMBER","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Randomization until Disease Progression Up to 38.01 Months","title":"Percentage of Participants Achieving an Objective Response (Objective Response Rate)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}