{"analyses":[{"ciLowerLimit":"0.839","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.113","estimateComment":"Hazard ratio is presented as panitumumab : cetuximab. A value \\< 1.0 indicates a lower average event rate and longer time to event for panitumumab relative to cetuximab.","groupDescription":"Cox proportional hazards model stratified by geographic region (North America, western Europe and Australia vs rest of world) and ECOG performance status (0 or 1 vs 2).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Stratified Cox proportional hazard ratio","paramValue":"0.966"},{"groupDescription":"A synthesis approach with an asymptotic standard normal test statistic based on the logarithm of the hazard ratio was used to test the hypothesis that panitumumab is non-inferior to cetuximab for overall survival (ie, that panitumumab retains at least 50% of the overall survival benefit of cetuximab relative to best supportive care).","groupIds":["OG000","OG001"],"nonInferiorityComment":"The overall survival non-inferiority hypothesis based on an asymptotic normal score was tested at a 1-sided 2.5% significance level. A value \\< -1.96 indicates non-inferiority at a significance level of 1-sided 0.025.","nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE_LEGACY","pValue":"0.0007","pValueComment":"A synthesis approach with an asymptotic standard normal test statistic","paramType":"Normal score","paramValue":"-3.19","statisticalMethod":"Asymptotic standard normal test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.3","upperLimit":"11.0","value":"10.0"},{"groupId":"OG001","lowerLimit":"9.4","upperLimit":"11.6","value":"10.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"500"},{"groupId":"OG001","value":"499"}],"units":"Participants"}],"description":"Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.","dispersionType":"95% Confidence Interval","groups":[{"description":"Cetuximab 400 mg/m\\^2 as an initial dose, followed by 250 mg/m\\^2 intravenously (IV) every 7 days.","id":"OG000","title":"Cetuximab"},{"description":"Panitumumab 6 mg/kg IV every 14 days.","id":"OG001","title":"Panitumumab"}],"paramType":"MEDIAN","populationDescription":"Primary Analysis Set: All participants who were randomized and who received at least 1 dose of panitumumab or cetuximab; analyzed according to randomized treatment arm.","reportingStatus":"POSTED","timeFrame":"From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}