{"analyses":[{"estimateComment":"A normal score \\<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.","groupDescription":"An overall 5% significance level was used to compare treatments with respect to both overall survival (OS) and PFS. A 4% and 1% level (2-sided) was used to independently test OS and PFS, respectively.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0036","paramType":"Normal score","paramValue":"-2.91","statisticalComment":"P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure, and prior oxaliplatin exposure (yes or no).","statisticalMethod":"Stratified log-rank test"},{"estimateComment":"A normal score \\<0 indicates fewer than expected events for the Panitumumab plus FOLFIRI arm and therefore a longer progression-free survival time.","groupDescription":"PFS in the Mutant Efficacy Analysis Set was compared at a 1% level conditional upon first demonstrating a significant difference in PFS in the Wild-type KRAS Efficacy Analysis Set.","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.1448","paramType":"Normal score","paramValue":"-1.46","statisticalComment":"P-value based on a 2-sided log-rank test stratified by ECOG (0 or 1 vs. 2), prior bevacizumab exposure and prior oxaliplatin exposure (yes or no).","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.5","upperLimit":"6.7","value":"5.9"},{"groupId":"OG001","lowerLimit":"3.7","upperLimit":"5.3","value":"3.9"},{"groupId":"OG002","lowerLimit":"3.8","upperLimit":"5.6","value":"5.0"},{"groupId":"OG003","lowerLimit":"3.6","upperLimit":"5.6","value":"4.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"303"},{"groupId":"OG001","value":"294"},{"groupId":"OG002","value":"238"},{"groupId":"OG003","value":"248"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from randomization to first disease progression per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria or death, based on independent central radiological assessment. Participants who were alive but did not meet criteria for progression by the data cutoff date were censored at their last evaluable disease assessment date.\n\nProgressive disease is defined as a ≥ 20% increase in the size of target lesions or unequivocal progression of existing non-target lesions or any new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG000","title":"Wild-type KRAS - Panitumumab Plus FOLFIRI"},{"description":"Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG001","title":"Wild-type KRAS - FOLFIRI Alone"},{"description":"Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG002","title":"Mutant KRAS - Panitumumab Plus FOLFIRI"},{"description":"Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG003","title":"Mutant KRAS - FOLFIRI Alone"}],"paramType":"MEDIAN","populationDescription":"KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 8 April 2008. Maximum follow-up time was 17 months.","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}