{"analyses":[{"ciLowerLimit":"0.713","ciNumSides":"TWO_SIDED","ciPctValue":"95.34","ciUpperLimit":"0.937","estimateComment":"Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0032","pValueComment":"Stratified Log-Rank test p-value. Stratified on ECOG Performance Status and prior Bevacizumab according to IVRS using the Cox Proportional Hazard Model. Significance threshold was set to 0.0466 using the O'Brien-Fleming alpha spending function.","paramType":"Stratified Hazard Ratio","paramValue":"0.817","statisticalMethod":"Stratified Log-Rank test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.83","upperLimit":"21.03","value":"12.06"},{"groupId":"OG001","lowerLimit":"7.62","upperLimit":"25.59","value":"13.50"}]}]}],"denomUnitsSelected":"Participants","denoms":[{"counts":[{"groupId":"OG000","value":"614"},{"groupId":"OG001","value":"612"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"460"},{"groupId":"OG001","value":"403"}],"units":"Events (Death)"}],"description":"Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).\n\nOS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.","dispersionType":"Inter-Quartile Range","groups":[{"description":"Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks","id":"OG000","title":"Placebo/FOLFIRI"},{"description":"Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks","id":"OG001","title":"Aflibercept/FOLFIRI"}],"paramType":"MEDIAN","populationDescription":"Intent-to-treat population (ITT) - all participants who gave informed consent and were randomized.","reportingStatus":"POSTED","timeFrame":"From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)","title":"Overall Survival (OS)","type":"PRIMARY","typeUnitsAnalyzed":"Events (Death)","unitOfMeasure":"months"}