{"analyses":[{"ciLowerLimit":"-40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-24","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","paramType":"Difference in Symptom Rate","paramValue":"-32.2"},{"ciLowerLimit":"-32","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-16","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":"Difference in Symptom Rate","paramValue":"-24.2"},{"ciLowerLimit":"-2.3","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.4","estimateComment":"Direction of comparison: Trastuzumab Emtansine + Pertuzumab vs Trastuzumab Emtansine + Placebo","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":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference in Symptom Rate","paramValue":"8.0"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"88.48","upperLimit":"96.06","value":"93.1"},{"groupId":"OG001","lowerLimit":"53.39","upperLimit":"67.93","value":"60.8"},{"groupId":"OG002","lowerLimit":"61.32","upperLimit":"75.92","value":"68.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"173"},{"groupId":"OG001","value":"171"},{"groupId":"OG002","value":"154"}],"units":"Participants"}],"description":"The FACT-Taxane is a self-reported instrument which measures the health-related quality of life (HRQOL) of participants receiving taxane-containing chemotherapy. The FACT-TaxS consists of 16 items including 11 neurotoxicity-related questions and 5 additional questions assessing arthralgia, myalgia, and skin discoloration. Items are rated from 0 (not at all) to 4 (very much) and a total score is inversely derived. Scores may range from 0 to 64, with higher scores indicating fewer/no symptoms. A minimally clinically important difference in treatment-related symptoms was defined as a ≥5% decrease (ie, 3.2 points) in FACT-TaxS score from Baseline. The percentage of participants with treatment-related symptoms was calculated using following formula: \\[number of participants meeting the above threshold 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 (Protocol Amendment C Subpopulation): All randomized participants who entered the study after Protocol Amendment C.","reportingStatus":"POSTED","timeFrame":"Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)","title":"Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score","type":"SECONDARY","unitOfMeasure":"percentage of participants"}