{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.34","value":"22.22"},{"groupId":"OG001","spread":"24.97","value":"21.94"},{"groupId":"OG002","spread":"25.86","value":"22.50"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"80"}],"units":"Participants"}],"title":"Baseline (BL): Value at Visit"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.01","value":"1.26"},{"groupId":"OG001","spread":"26.25","value":"2.95"},{"groupId":"OG002","spread":"27.81","value":"-0.42"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"80"}],"units":"Participants"}],"title":"Change from BL at Cycle 3 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.86","value":"1.72"},{"groupId":"OG001","spread":"29.34","value":"5.26"},{"groupId":"OG002","spread":"30.15","value":"-1.69"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"76"},{"groupId":"OG002","value":"79"}],"units":"Participants"}],"title":"Change from BL at Cycle 6 Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"31.75","value":"-0.94"},{"groupId":"OG001","spread":"32.15","value":"3.76"},{"groupId":"OG002","spread":"30.85","value":"-5.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"71"}],"units":"Participants"}],"title":"Change from BL at Cycle 15 or Last Treatment Cycle"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.95","value":"-0.23"},{"groupId":"OG001","spread":"30.07","value":"1.85"},{"groupId":"OG002","spread":"31.85","value":"-2.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"72"},{"groupId":"OG002","value":"74"}],"units":"Participants"}],"title":"Change from BL at 1.5 Years"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"33.89","value":"2.97"},{"groupId":"OG001","spread":"35.56","value":"6.85"},{"groupId":"OG002","spread":"31.90","value":"-0.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"146"},{"groupId":"OG001","value":"73"},{"groupId":"OG002","value":"73"}],"units":"Participants"}],"title":"Change from BL at 2 Years"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.08","value":"0.00"},{"groupId":"OG001","spread":"33.79","value":"1.47"},{"groupId":"OG002","spread":"34.58","value":"-1.54"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"68"},{"groupId":"OG002","value":"65"}],"units":"Participants"}],"title":"Change from BL at 3 Years"}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"79"},{"groupId":"OG002","value":"80"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 questionnaire consisted of 30 questions covering treatment-related symptoms, functioning, and GHS/HRQoL. Questions were answered by participants on a scale from 1 to 4 or 1 to 7. Raw scores were transformed to scale scores that ranged from 0 to 100 where a higher scale score indicating a higher response (i.e., on the functioning and GHS/QoL scales a higher score meant better functioning/QoL, whereas on the symptom scales a higher score meant greater \\[worse\\] symptoms). The EORTC QLQ-C30 data was scored according to the EORTC scoring manual (Fayers 2001). In the event of incomplete data, for all questionnaire subscales, if more than 50% of the constituent items are completed, a pro-rated score was to be computed consistent with the scoring manuals and published validation reports. For subscales with less than 50% of the items completed, the subscale was to be considered as missing.","dispersionType":"Standard Deviation","groups":[{"description":"In the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"OG000","title":"All Participants"},{"description":"In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"OG001","title":"A: P+H IV Followed by PH FDC SC"},{"description":"In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.","id":"OG002","title":"B: PH FDC SC Followed by P+H IV"}],"paramType":"MEAN","populationDescription":"The Patient-Reported Outcome (PRO)-Evaluable Population includes all participants in the ITT population with a baseline EORTC QLQ-C30 assessment and at least one post-baseline EORTC QLQ-C30 assessment. The number analyzed at a given timepoint indicates participants with non-missing data at that timepoint.","reportingStatus":"POSTED","timeFrame":"Baseline (Day 1 of Cycle 1); Day 1 of Cycles 3, 6, and 15 (or last treatment cycle; each cycle is 21 days); 1.5, 2, and 3 years (up to 3 years)","title":"Change From Baseline Over Time in the Insomnia Scale Score of the EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"score on a scale"}