{"analyses":[{"ciLowerLimit":"0.578","ciNumSides":"TWO_SIDED","ciPctValue":"99.99","ciUpperLimit":"0.995","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.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.00007","pValueComment":"Stratified on ECOG Performance Status (0 vs 1 vs 2) and prior Bevacizumab (yes vs no) according to IVRS","paramType":"Stratified Hazard ratio","paramValue":"0.758","statisticalMethod":"Stratified Log-Rank test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.60","upperLimit":"9.10","value":"4.67"},{"groupId":"OG001","lowerLimit":"3.84","upperLimit":"10.05","value":"6.90"}]}]}],"denomUnitsSelected":"Participants","denoms":[{"counts":[{"groupId":"OG000","value":"614"},{"groupId":"OG001","value":"612"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"454"},{"groupId":"OG001","value":"393"}],"units":"First PFS Events"}],"description":"PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.\n\nPFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.\n\nThe analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.","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 (ITT) population included all participants who gave informed consent and were randomized.","reportingStatus":"POSTED","timeFrame":"From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)","title":"Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)","type":"SECONDARY","typeUnitsAnalyzed":"First PFS Events","unitOfMeasure":"months"}