{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"30"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"LVEF Increase/No Change/Decrease FromBL <10%Points"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"LVEF <50% and Decrease From BL ≥10% to <15% Points"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"LVEF <50% and Decrease From BL ≥15% Points"},{"categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"115"},{"groupId":"OG002","value":"15"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"LVEF ≥50% and Decrease From BL ≥10% Points"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"},{"groupId":"OG001","value":"394"},{"groupId":"OG002","value":"49"}],"units":"Participants"}],"title":"No Baseline (BL) LVEF Value"}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"description":"All participants were required to have an 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. Data reported prior to first crossover treatment were included in the Placebo arm, and after that date in the Crossover arm, for participants who crossed over from placebo to pertuzumab. Median \\[range\\] time on study treatment per arm: Placebo: 49.3 \\[0.3-514.7\\] weeks; Pertuzumab: 75.7 \\[0.6-519.6\\] weeks; Crossover: 129.9 \\[0.3-322.3\\] weeks.","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"},{"description":"Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. 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":"OG002","title":"Crossover From Placebo to Pertuzumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population: All participants who received at least one dose of any study medication. Only participants with evaluable LVEF assessments during the overall study treatment period were included in the analysis.","reportingStatus":"POSTED","timeFrame":"Every 9 weeks from the date of randomization until Treatment Discontinuation Visit (see Description for time on study treatment per arm)","title":"Number of Participants by Categories for the Maximum Absolute Decrease From Baseline in LVEF Value During the Treatment Period","type":"SECONDARY","unitOfMeasure":"Participants"}