{"analyses":[{"ciLowerLimit":"0.57","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.86","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":"Hazard Ratio (HR)","paramValue":"0.70"},{"ciLowerLimit":"0.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.84","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":"0.68"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.0","upperLimit":"4.4","value":"3.6"},{"groupId":"OG001","lowerLimit":"6.2","upperLimit":"11.9","value":"7.7"},{"groupId":"OG002","lowerLimit":"5.1","upperLimit":"14.5","value":"9.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"327"},{"groupId":"OG001","value":"352"},{"groupId":"OG002","value":"338"}],"units":"Participants"}],"description":"The FACT-B is a self-reported instrument which measures HRQOL of participants with breast cancer. It consists of 5 subscales including PWB, SWB, EWB, FWB, and BCS. The TOI-PFB score is taken by adding the scores from the PWB (7 items), FWB (7 items), and BCS (9 items) subscales. Items are rated from 0 (not at all) to 4 (very much) and a total score is derived. Scores may range from 0 to 92, with higher scores indicating better HRQOL. A 5 point change has been identified as the clinically minimal important difference (CMID) on the FACT-TOI-PFB scale. Time to deterioration was defined as the time from Baseline until the first decrease in FACT-B TOI-PFB score. Median time to deterioration 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. Number of participants analyzed=participants with baseline and at least one post baseline FACT-B TOI-PFB score.","reportingStatus":"POSTED","timeFrame":"Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014","title":"Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score","type":"SECONDARY","unitOfMeasure":"months"}