{"analyses":[{"ciLowerLimit":"0.73","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.20","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane","groupDescription":"Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \\[trastuzumab and/or lapatinib\\], yes \\[no trastuzumab and/or lapatinib\\]), and visceral disease (present, absent).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.6568","paramType":"Hazard Ratio (HR)","paramValue":"0.93","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.11","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane","groupDescription":"Stratified Analysis: Stratification factors included world region (United States, Western Europe/Canada/Australia-Pacific, Eastern Europe, Asia, others); prior adjuvant/neoadjuvant therapy (no, yes \\[trastuzumab and/or lapatinib\\], yes \\[no trastuzumab and/or lapatinib\\]), and visceral disease (present, absent).","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.5691","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"44.75","upperLimit":"60.75","value":"50.86"},{"groupId":"OG001","lowerLimit":"48.36","upperLimit":"64.36","value":"53.68"},{"comment":"Upper limit of CI was not reached due to low number of participants with events.","groupId":"OG002","lowerLimit":"47.87","upperLimit":"NA","value":"51.78"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"},{"groupId":"OG002","value":"363"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to death from any cause. Median duration of OS was estimated using Kaplan-Meier analysis, and corresponding CIs were computed using the Brookmeyer-Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m\\^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m\\^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.","id":"OG000","title":"Trastuzumab + Taxane"},{"description":"Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"OG001","title":"Trastuzumab Emtansine + Placebo"},{"description":"Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.","id":"OG002","title":"Trastuzumab Emtansine + Pertuzumab"}],"paramType":"MEDIAN","populationDescription":"ITT Population.","reportingStatus":"POSTED","timeFrame":"Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)","title":"Overall Survival (OS) at Clinical Cutoff","type":"SECONDARY","unitOfMeasure":"months"}