{"analyses":[{"ciLowerLimit":"0.679","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.918","estimateComment":"Cox regression model with treatment as the independent variable, stratified by randomization strata. Hazard ratio with control as reference.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.6188","paramType":"Hazard Ratio (HR)","paramValue":"1.141","statisticalMethod":"From a stratified log-rank test, stratif"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"42.4","value":"17.2"},{"groupId":"OG001","lowerLimit":"0.3","upperLimit":"40.2","value":"18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"72"}],"units":"Participants"}],"description":"Overall survival is defined as the time from randomization to death due to any cause.\n\n\\*This study was terminated early due to administrative reasons.","dispersionType":"Full Range","groups":[{"description":"DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.","id":"OG000","title":"DN24-02"},{"description":"Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.\n\nStandard of Care: Standard of care","id":"OG001","title":"Standard of Care"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat (ITT) population.\n\n\\*This study was terminated early due to administrative reasons.","reportingStatus":"POSTED","timeFrame":"Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"Months"}