{"analyses":[{"estimateComment":"A normal score \\<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.","groupDescription":"PFS in the Wild-type KRAS Efficacy Analysis Set was compared at a significance level of 5%.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0234","pValueComment":"P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).","paramType":"Normal score","paramValue":"-2.27","statisticalMethod":"Stratified log-rank test"},{"estimateComment":"A normal score \\<0 indicates fewer than expected events for the panitumumab plus FOLFOX arm and therefore a longer progression-free survival time.","groupDescription":"PFS in the Mutant KRAS Efficacy Analysis Set was compared at a significance level of 5% conditional on first demonstrating a significant treatment effect in PFS in the Wild-type KRAS Efficacy Analysis Set.","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0227","pValueComment":"P-value is based on a 2-sided log-rank test stratified by Region (Western Europe, Canada and Australia vs. Rest of World) and ECOG score (0 or 1 vs. 2).","paramType":"Normal score","paramValue":"2.28","statisticalMethod":"Stratified log-rank test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.2","upperLimit":"11.1","value":"9.6"},{"groupId":"OG001","lowerLimit":"7.5","upperLimit":"9.3","value":"8.0"},{"groupId":"OG002","lowerLimit":"6.3","upperLimit":"8.0","value":"7.3"},{"groupId":"OG003","lowerLimit":"7.7","upperLimit":"9.4","value":"8.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"325"},{"groupId":"OG001","value":"331"},{"groupId":"OG002","value":"221"},{"groupId":"OG003","value":"219"}],"units":"Participants"}],"description":"Progression-free survival (PFS), assessed by central radiological assessment, was defined as the time from randomization to disease progression per modified response evaluation criteria in solid tumors (RECIST) criteria or death. 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. Progressive 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 panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.","id":"OG000","title":"Wild-type KRAS - FOLFOX + Panitumumab"},{"description":"Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.","id":"OG001","title":"Wild-type KRAS - FOLFOX"},{"description":"Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.","id":"OG002","title":"Mutant KRAS - FOLFOX + Panitumumab"},{"description":"Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.","id":"OG003","title":"Mutant KRAS - FOLFOX"}],"paramType":"MEDIAN","populationDescription":"KRAS Efficacy Analysis Set (participants for whom KRAS status was assessed)","reportingStatus":"POSTED","timeFrame":"From randomization until the data cutoff date of 30 September 2008. Maximum follow-up time was 109 weeks.","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"months"}