{"analyses":[{"ciLowerLimit":"0.422","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.661","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":"<0.0001","pValueComment":"The two-sided stratified log-rank test was used to compare progression-free survival between the two treatment arms at the overall two-sided significance level of 0.5%.","paramType":"Hazard Ratio (HR)","paramValue":"0.528","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.59","upperLimit":"6.87","value":"6.2"},{"groupId":"OG001","lowerLimit":"2.89","upperLimit":"4.14","value":"3.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"Progression-free survival was defined as the time from randomization to the first documented disease progression by investigator assessment using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurred first. Progression-free 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":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"Months"}