{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"97.5","ciUpperLimit":"1.25","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Hazard Ratio (HR)","paramValue":"0.90"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.1","upperLimit":"46.4","value":"15.9"},{"groupId":"OG001","lowerLimit":"0.1","upperLimit":"46.0","value":"18.6"},{"groupId":"OG002","lowerLimit":"0.1","upperLimit":"48.1","value":"18.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"165"},{"groupId":"OG002","value":"173"}],"units":"Participants"}],"description":"Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. 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.","dispersionType":"Full Range","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 (High HER2 mRNA Subpopulation).","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 IRF Assessment Among Those With High HER2 mRNA Levels","type":"SECONDARY","unitOfMeasure":"months"}