{"analyses":[{"groupDescription":"Wilcoxon Test of Maximum Decrease in LVEF From BL","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.7174","statisticalMethod":"Wilcoxon Rank Sum Test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.51","value":"65.6"},{"groupId":"OG001","spread":"6.71","value":"64.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"393"},{"groupId":"OG001","value":"406"}],"units":"Participants"}],"title":"Baseline (BL) LVEF Value"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.15","value":"-7.3"},{"groupId":"OG001","spread":"7.75","value":"-7.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"375"},{"groupId":"OG001","value":"392"}],"units":"Participants"}],"title":"Change in LVEF From BL at Maximum Decrease Value"}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"}],"units":"Participants"}],"description":"All participants were required to have a left ventricular ejection fraction (LVEF) ≥50% at baseline, as measured by echocardiogram (preferred) or multiple-gated acquisition (MUGA) scan. The same method of LVEF assessment and the same institution/facility used at baseline was used throughout the study, to the extent possible. The baseline value was defined as the last valid value recorded during the pre-treatment period before or on study Day 1. The maximum absolute decrease in LVEF value was defined as the lowest post-baseline value up to the end of the overall study treatment period. Only data reported prior to the date of first crossover treatment were included for participants who crossed over from placebo to pertuzumab.","dispersionType":"Standard Deviation","groups":[{"description":"This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG000","title":"Placebo + Trastuzumab + Docetaxel"},{"description":"This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG001","title":"Pertuzumab + Trastuzumab + Docetaxel"}],"paramType":"MEAN","populationDescription":"Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments at baseline (BL) or at BL and post-BL (for change in LVEF from BL at max. decrease) were included in the analyses.","reportingStatus":"POSTED","timeFrame":"Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (median [range] time on study treatment per arm: Placebo: 49.3 [0.3-514.7] weeks; Pertuzumab: 75.7 [0.6-519.6] weeks)","title":"Baseline LVEF Value and Change in LVEF From Baseline at Maximum Absolute Decrease Value During the Treatment Period","type":"SECONDARY","unitOfMeasure":"Percentage points of LVEF"}