{"analyses":[{"ciLowerLimit":"0.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"37.3","estimateComment":"Stratified analysis","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1697","paramType":"Odds Ratio (OR)","paramValue":"4.6","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4.6"},{"groupId":"OG001","value":"1.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"197"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.","groups":[{"description":"8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.","id":"OG000","title":"Ramucirumab + BSC"},{"description":"Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.\n\nParticipants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.","id":"OG001","title":"Placebo + BSC"}],"paramType":"NUMBER","populationDescription":"All randomized participants who received at least one dose of study drug.","reportingStatus":"POSTED","timeFrame":"From Randomization to Objective Progression (Up to 28 Months)","title":"Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}