{"analyses":[{"ciLowerLimit":"-15.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-0.5","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Placebo vs Trastuzumab + Taxane","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference in Response Rate","paramValue":"-8.2"},{"ciLowerLimit":"-11.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.9","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab + Taxane","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference in Response Rate","paramValue":"-3.7"},{"ciLowerLimit":"-3.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.2","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference in Response Rate","paramValue":"4.5"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"62.26","upperLimit":"73.31","value":"67.9"},{"groupId":"OG001","lowerLimit":"54.07","upperLimit":"65.30","value":"59.7"},{"groupId":"OG002","lowerLimit":"58.62","upperLimit":"69.65","value":"64.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"287"},{"groupId":"OG001","value":"303"},{"groupId":"OG002","value":"299"}],"units":"Participants"}],"description":"Objective response was defined as having complete response (CR) or partial response (PR), assessed 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. CR was defined as the disappearance of all target and non-target lesions and short-axis reduction in pathological lymph nodes to \\<10 mm. PR was defined as a ≥30% decrease in sum of diameters of target lesions, taking as reference the Baseline sum. Response was determined using 2 consecutive tumor assessments at least 4 weeks apart. The percentage of participants with a best overall response of CR or PR (ie, the objective response rate \\[ORR\\]) was calculated as \\[number of participants meeting the respective criteria divided by the number analyzed\\] multiplied by 100. Corresponding CIs were computed using the Blyth-Still-Casella exact 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":"NUMBER","populationDescription":"ITT Population. Only participants with measurable disease at Baseline were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Up to 46 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":"Percentage of Participants With Objective Response According to IRF Assessment","type":"SECONDARY","unitOfMeasure":"percentage of participants"}