{"analyses":[{"ciLowerLimit":"0.69","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.04","estimateComment":"Direction of comparison: Trastuzumab Emtasine + 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","paramType":"Hazard Ratio (HR)","paramValue":"0.85"},{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"0.95","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","paramType":"Hazard Ratio (HR)","paramValue":"0.77"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.5","upperLimit":"13.6","value":"12.5"},{"groupId":"OG001","lowerLimit":"12.2","upperLimit":"16.7","value":"14.1"},{"groupId":"OG002","lowerLimit":"12.4","upperLimit":"17.8","value":"14.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"},{"groupId":"OG002","value":"363"}],"units":"Participants"}],"description":"Tumor assessments were performed by the investigator according to RECIST version 1.1. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS 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 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)","title":"PFS According to Investigator Assessment","type":"SECONDARY","unitOfMeasure":"months"}