{"analyses":[{"ciLowerLimit":"0.369","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.826","estimateComment":"The hazard ratio was estimated by Cox regression.","groupDescription":"The analysis was stratified for 1) World region (United States, Western Europe, or Other); 2) Number of prior regimens, excluding single-agent hormones, for treatment of metastatic or unresectable locally advanced/recurrent disease (≤ 3 or \\> 3); and 3) Presence of visceral disease (any visceral disease vs no visceral disease).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0034","pValueComment":"The 2-sided stratified log-rank test was used at the overall two-sided significance level of 4.5%. The pre-specified O'Brien-Fleming stopping boundary for this first OS interim analysis was HR\\<0.363 (p-value \\< 0.0000013).","paramType":"Hazard Ratio (HR)","paramValue":"0.552","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"comment":"The median and the upper limit of the confidence interval could not be estimated due to too few events.","groupId":"OG000","lowerLimit":"13.14","upperLimit":"NA","value":"NA"},{"comment":"The upper limit of the confidence interval could not be estimated due to too few events.","groupId":"OG001","lowerLimit":"11.27","upperLimit":"NA","value":"14.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"Overall survival (OS) was defined as the time from randomization to death from any cause. Overall survival was a co-primary endpoint.","dispersionType":"95% Confidence Interval","groups":[{"description":"Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.","id":"OG000","title":"Trastuzumab Emtansine"},{"description":"Treatment of physician's choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.","id":"OG001","title":"Treatment of Physician's Choice"}],"paramType":"MEDIAN","populationDescription":"Randomized population: All participants who were randomized to the study. Participants were included in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Baseline to the clinical cut-off date of 11 Feb 2013 (up to 2 years)","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"Months"}