{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"72.9"},{"groupId":"OG001","spread":"19.7","value":"72.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2329"},{"groupId":"OG001","value":"2338"}],"units":"Participants"}],"title":"Baseline"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.8","value":"-11.2"},{"groupId":"OG001","spread":"22.6","value":"-10.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2065"},{"groupId":"OG001","value":"2110"}],"units":"Participants"}],"title":"Change at Week 13"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.6","value":"-4.4"},{"groupId":"OG001","spread":"21.0","value":"-2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2035"},{"groupId":"OG001","value":"2073"}],"units":"Participants"}],"title":"Change at Week 25"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.9","value":"-3.1"},{"groupId":"OG001","spread":"21.8","value":"-1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2254"},{"groupId":"OG001","value":"2282"}],"units":"Participants"}],"title":"Change at EOT"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.5","value":"1.9"},{"groupId":"OG001","spread":"22.2","value":"1.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1906"},{"groupId":"OG001","value":"1918"}],"units":"Participants"}],"title":"Change at FU Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.1","value":"2.2"},{"groupId":"OG001","spread":"22.1","value":"2.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1861"},{"groupId":"OG001","value":"1866"}],"units":"Participants"}],"title":"Change at FU Month 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.4","value":"2.8"},{"groupId":"OG001","spread":"22.5","value":"1.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1811"},{"groupId":"OG001","value":"1782"}],"units":"Participants"}],"title":"Change at FU Month 36"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2329"},{"groupId":"OG001","value":"2338"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. First 28 questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \\[N/V\\], constipation, and pain) and a single item (financial difficulties). Last 2 questions represented participant's assessment of overall health and quality of life, used 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100, with a high score indicating better GHS/QOL. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).","id":"OG000","title":"Pertuzumab + Trastuzumab + Chemotherapy"},{"description":"Participants received placebo matched to pertuzumab IV Q3W and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\\^2 + epirubicin 90-120 mg/m\\^2 or doxorubicin 50 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\\^2 for 3 cycles, 75 mg/m\\^2 in first cycle and 100 mg/m\\^2 in subsequent cycles, or 75 mg/m\\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\\^2 or epirubicin 90-120 mg/m\\^2 + cyclophosphamide 500-600 mg/m\\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\\^2 + carboplatin AUC 6 (up to 900 mg).","id":"OG001","title":"Placebo + Trastuzumab + Chemotherapy"}],"paramType":"MEAN","populationDescription":"ITT population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed=number of participants responding to this scale where it is considered complete as defined by the EORTC QLQ-C30 scoring manual.","reportingStatus":"POSTED","timeFrame":"Baseline, Weeks 13, 25; end of treatment (EOT, 28 days after the last dose, up to Week 56); Follow-up (FU) Months 18, 24, 36","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score","type":"SECONDARY","unitOfMeasure":"units on a scale"}