{"analyses":[{"ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","statisticalComment":"Stratified on ECOG Performance Status (0 vs 1 vs 2) and Prior Bevacizumab (yes vs no) according to IVRS.","statisticalMethod":"Stratified Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.5","upperLimit":"13.8","value":"11.1"},{"groupId":"OG001","lowerLimit":"16.4","upperLimit":"23.2","value":"19.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"530"},{"groupId":"OG001","value":"531"}],"units":"Participants"}],"description":"The overall ORR was the percentage of evaluable participants who achieved complete response \\[CR\\] or partial response \\[PR\\] according to RECIST criteria version 1.0.\n\n* CR reflected the disappearance of all tumor lesions (with no new tumors)\n* PR reflected a pre-defined reduction in tumor burden\n\nTumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.","dispersionType":"95% Confidence Interval","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":"NUMBER","populationDescription":"The evaluable patient population (EPP) for tumor response included all randomized participants with measurable disease at study entry, as per IRC evaluation, and with at least one valid post-baseline tumor evaluation.","reportingStatus":"POSTED","timeFrame":"From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)","title":"Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria","type":"SECONDARY","unitOfMeasure":"percentage of participants"}