{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"14.4","value":"5.2"},{"groupId":"OG001","spread":"13.5","value":"5.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2329"},{"groupId":"OG001","value":"2339"}],"units":"Participants"}],"title":"Baseline: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.8","value":"22.3"},{"groupId":"OG001","spread":"23.9","value":"9.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2067"},{"groupId":"OG001","value":"2111"}],"units":"Participants"}],"title":"Change at Week 13: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.5","value":"13.2"},{"groupId":"OG001","spread":"19.8","value":"3.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2043"},{"groupId":"OG001","value":"2075"}],"units":"Participants"}],"title":"Change at Week 25: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.9","value":"12.2"},{"groupId":"OG001","spread":"20.0","value":"2.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2257"},{"groupId":"OG001","value":"2285"}],"units":"Participants"}],"title":"Change at EOT: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.7","value":"-0.5"},{"groupId":"OG001","spread":"17.5","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1907"},{"groupId":"OG001","value":"1919"}],"units":"Participants"}],"title":"Change at FU Month 18: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"17.4","value":"-0.8"},{"groupId":"OG001","spread":"18.3","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1861"},{"groupId":"OG001","value":"1868"}],"units":"Participants"}],"title":"Change at FU Month 24: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.5","value":"-0.8"},{"groupId":"OG001","spread":"16.9","value":"0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1810"},{"groupId":"OG001","value":"1784"}],"units":"Participants"}],"title":"Change at FU Month 36: Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.7","value":"22.4"},{"groupId":"OG001","spread":"20.5","value":"23.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2335"},{"groupId":"OG001","value":"2341"}],"units":"Participants"}],"title":"Baseline: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.3","value":"16.1"},{"groupId":"OG001","spread":"24.4","value":"16.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2074"},{"groupId":"OG001","value":"2116"}],"units":"Participants"}],"title":"Change at Week 13: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.5","value":"7.8"},{"groupId":"OG001","spread":"22.3","value":"6.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2050"},{"groupId":"OG001","value":"2078"}],"units":"Participants"}],"title":"Change at Week 25: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"7.1"},{"groupId":"OG001","spread":"23.0","value":"5.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2259"},{"groupId":"OG001","value":"2287"}],"units":"Participants"}],"title":"Change at EOT: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.7","value":"1.1"},{"groupId":"OG001","spread":"22.5","value":"1.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1914"},{"groupId":"OG001","value":"1924"}],"units":"Participants"}],"title":"Change at FU Month 18: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.0","value":"0.4"},{"groupId":"OG001","spread":"22.6","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1864"},{"groupId":"OG001","value":"1873"}],"units":"Participants"}],"title":"Change at FU Month 24: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.8","value":"-0.2"},{"groupId":"OG001","spread":"22.8","value":"0.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1817"},{"groupId":"OG001","value":"1791"}],"units":"Participants"}],"title":"Change at FU Month 36: Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.5","value":"6.8"},{"groupId":"OG001","spread":"17.1","value":"8.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2331"},{"groupId":"OG001","value":"2336"}],"units":"Participants"}],"title":"Baseline: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.8","value":"12.3"},{"groupId":"OG001","spread":"26.4","value":"14.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2067"},{"groupId":"OG001","value":"2112"}],"units":"Participants"}],"title":"Change at Week 13: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.9","value":"6.3"},{"groupId":"OG001","spread":"22.1","value":"6.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2045"},{"groupId":"OG001","value":"2073"}],"units":"Participants"}],"title":"Change at Week 25: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.5","value":"6.6"},{"groupId":"OG001","spread":"22.5","value":"6.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2254"},{"groupId":"OG001","value":"2283"}],"units":"Participants"}],"title":"Change at EOT: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.0","value":"5.9"},{"groupId":"OG001","spread":"21.5","value":"5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1911"},{"groupId":"OG001","value":"1917"}],"units":"Participants"}],"title":"Change at FU Month 18: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.5","value":"5.1"},{"groupId":"OG001","spread":"22.4","value":"5.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1860"},{"groupId":"OG001","value":"1870"}],"units":"Participants"}],"title":"Change at FU Month 24: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.5","value":"5.1"},{"groupId":"OG001","spread":"22.3","value":"5.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1814"},{"groupId":"OG001","value":"1783"}],"units":"Participants"}],"title":"Change at FU Month 36: Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.2","value":"8.5"},{"groupId":"OG001","spread":"18.7","value":"9.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2335"},{"groupId":"OG001","value":"2340"}],"units":"Participants"}],"title":"Baseline: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.2","value":"13.6"},{"groupId":"OG001","spread":"27.9","value":"7.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2073"},{"groupId":"OG001","value":"2114"}],"units":"Participants"}],"title":"Change at Week 13: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.1","value":"5.2"},{"groupId":"OG001","spread":"22.4","value":"0.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2049"},{"groupId":"OG001","value":"2078"}],"units":"Participants"}],"title":"Change at Week 25: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.5","value":"3.0"},{"groupId":"OG001","spread":"22.6","value":"-0.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2257"},{"groupId":"OG001","value":"2286"}],"units":"Participants"}],"title":"Change at EOT: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.1","value":"-3.0"},{"groupId":"OG001","spread":"21.1","value":"-3.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1913"},{"groupId":"OG001","value":"1924"}],"units":"Participants"}],"title":"Change at FU Month 18: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.6","value":"-3.2"},{"groupId":"OG001","spread":"21.0","value":"-3.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1862"},{"groupId":"OG001","value":"1871"}],"units":"Participants"}],"title":"Change at FU Month 24: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"20.4","value":"-3.0"},{"groupId":"OG001","spread":"21.2","value":"-2.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1817"},{"groupId":"OG001","value":"1789"}],"units":"Participants"}],"title":"Change at FU Month 36: Appetite Loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.4","value":"25.3"},{"groupId":"OG001","spread":"28.5","value":"27.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2333"},{"groupId":"OG001","value":"2338"}],"units":"Participants"}],"title":"Baseline: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.3","value":"6.3"},{"groupId":"OG001","spread":"32.2","value":"5.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2073"},{"groupId":"OG001","value":"2111"}],"units":"Participants"}],"title":"Change at Week 13: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.6","value":"4.3"},{"groupId":"OG001","spread":"31.8","value":"2.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2049"},{"groupId":"OG001","value":"2073"}],"units":"Participants"}],"title":"Change at Week 25: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.0","value":"3.2"},{"groupId":"OG001","spread":"32.8","value":"0.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2257"},{"groupId":"OG001","value":"2282"}],"units":"Participants"}],"title":"Change at EOT: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.1","value":"-0.1"},{"groupId":"OG001","spread":"32.4","value":"0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1913"},{"groupId":"OG001","value":"1917"}],"units":"Participants"}],"title":"Change at FU Month 18: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.3","value":"-1.5"},{"groupId":"OG001","spread":"32.9","value":"-1.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1863"},{"groupId":"OG001","value":"1869"}],"units":"Participants"}],"title":"Change at FU Month 24: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.1","value":"-0.3"},{"groupId":"OG001","spread":"33.5","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1816"},{"groupId":"OG001","value":"1786"}],"units":"Participants"}],"title":"Change at FU Month 36: Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.2","value":"2.7"},{"groupId":"OG001","spread":"9.4","value":"3.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2338"},{"groupId":"OG001","value":"2342"}],"units":"Participants"}],"title":"Baseline: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"15.7","value":"5.6"},{"groupId":"OG001","spread":"14.5","value":"3.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2077"},{"groupId":"OG001","value":"2118"}],"units":"Participants"}],"title":"Change at Week 13: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.8","value":"1.1"},{"groupId":"OG001","spread":"12.4","value":"0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2052"},{"groupId":"OG001","value":"2079"}],"units":"Participants"}],"title":"Change at Week 25: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"12.7","value":"1.6"},{"groupId":"OG001","spread":"13.2","value":"0.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2261"},{"groupId":"OG001","value":"2288"}],"units":"Participants"}],"title":"Change at EOT: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.5","value":"-0.2"},{"groupId":"OG001","spread":"12.1","value":"-0.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1918"},{"groupId":"OG001","value":"1925"}],"units":"Participants"}],"title":"Change at FU Month 18: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"10.7","value":"0.0"},{"groupId":"OG001","spread":"11.8","value":"-0.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1865"},{"groupId":"OG001","value":"1874"}],"units":"Participants"}],"title":"Change at FU Month 24: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.0","value":"0.3"},{"groupId":"OG001","spread":"11.7","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1819"},{"groupId":"OG001","value":"1792"}],"units":"Participants"}],"title":"Change at FU Month 36: N/V"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"19.1","value":"8.7"},{"groupId":"OG001","spread":"19.8","value":"10.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2335"},{"groupId":"OG001","value":"2339"}],"units":"Participants"}],"title":"Baseline: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.5","value":"1.4"},{"groupId":"OG001","spread":"25.6","value":"4.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2066"},{"groupId":"OG001","value":"2113"}],"units":"Participants"}],"title":"Change at Week 13: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.8","value":"-0.7"},{"groupId":"OG001","spread":"22.8","value":"0.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2047"},{"groupId":"OG001","value":"2075"}],"units":"Participants"}],"title":"Change at Week 25: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.4","value":"0.1"},{"groupId":"OG001","spread":"23.3","value":"0.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2256"},{"groupId":"OG001","value":"2285"}],"units":"Participants"}],"title":"Change at EOT: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.3","value":"3.0"},{"groupId":"OG001","spread":"23.8","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1912"},{"groupId":"OG001","value":"1922"}],"units":"Participants"}],"title":"Change at FU Month 18: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.1","value":"2.1"},{"groupId":"OG001","spread":"22.9","value":"0.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1865"},{"groupId":"OG001","value":"1872"}],"units":"Participants"}],"title":"Change at FU Month 24: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.9","value":"2.1"},{"groupId":"OG001","spread":"22.7","value":"1.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1815"},{"groupId":"OG001","value":"1784"}],"units":"Participants"}],"title":"Change at FU Month 36: Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.4","value":"18.8"},{"groupId":"OG001","spread":"22.1","value":"19.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2337"},{"groupId":"OG001","value":"2342"}],"units":"Participants"}],"title":"Baseline: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.4","value":"2.3"},{"groupId":"OG001","spread":"26.1","value":"5.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2077"},{"groupId":"OG001","value":"2118"}],"units":"Participants"}],"title":"Change at Week 13: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.1","value":"1.4"},{"groupId":"OG001","spread":"24.9","value":"1.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2051"},{"groupId":"OG001","value":"2080"}],"units":"Participants"}],"title":"Change at Week 25: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.7","value":"0.1"},{"groupId":"OG001","spread":"25.8","value":"0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2261"},{"groupId":"OG001","value":"2288"}],"units":"Participants"}],"title":"Change at EOT: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.3","value":"-1.3"},{"groupId":"OG001","spread":"25.8","value":"-0.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1918"},{"groupId":"OG001","value":"1927"}],"units":"Participants"}],"title":"Change at FU Month 18: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.2","value":"-1.6"},{"groupId":"OG001","spread":"25.6","value":"-2.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1868"},{"groupId":"OG001","value":"1874"}],"units":"Participants"}],"title":"Change at FU Month 24: Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"24.4","value":"-2.6"},{"groupId":"OG001","spread":"25.0","value":"-2.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1818"},{"groupId":"OG001","value":"1792"}],"units":"Participants"}],"title":"Change at FU Month 36: Pain"}],"denoms":[{"counts":[{"groupId":"OG000","value":"2338"},{"groupId":"OG001","value":"2342"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall 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, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 disease/treatment-related symptom scores were linearly transformed on a scale of 0 to 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicated improvement in symptoms and positive values indicated worsening of symptoms.","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; EOT (28 days after the last dose, up to Week 56); FU Months 18, 24, 36","title":"Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores","type":"SECONDARY","unitOfMeasure":"units on a scale"}