{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.31","upperLimit":"4.34","value":"1.5"},{"groupId":"OG001","lowerLimit":"0.00","upperLimit":"1.85","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"Symptomatic left ventricular systolic dysfunction (otherwise referred to as heart failure) is a serious adverse event. The NYHA Functional Classification System for Heart Failure considers the patient's symptoms: Class III: Marked limitation of physical activity; Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV: Unable to carry on any physical activity without discomfort; Symptoms of heart failure at rest; If any physical activity is undertaken, discomfort increases. The 95% CIs were calculated with the Clopper-Pearson method. Results included events with onset from first dose of pertuzumab/trastuzumab prior to surgery through the day before the first dose of any study drug after surgery. If participant withdrew without entering adjuvant period, results included all events with onset from first dose of pertuzumab/trastuzumab through 42 days after last dose of any study drug or on the day of target surgery whichever was later.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received neoadjuvant treatment with dose-dense doxorubicin and cyclophosphamide (ddAC), with administration of doxorubicin 60 milligrams per square meter (mg/m\\^2) intravenously (IV) once every 2 weeks (q2w) and cyclophosphamide 600mg/m\\^2 IV q2w for 4 cycles, followed by paclitaxel 80mg/m\\^2 IV once weekly (qw) for 12 weeks. Pertuzumab (840 milligrams \\[mg\\] IV loading dose then 420mg IV q3w) and trastuzumab (8 milligrams per kilogram \\[mg/kg\\] IV loading dose then 4mg/kg IV q3w) were administered along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"OG000","title":"Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab"},{"description":"Participants received neoadjuvant treatment with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), with administration of 5-fluorouracil 500mg/m\\^2 intravenously (IV) q3w, epirubicin 100mg/m\\^2 IV q3w, and cyclophosphamide 600mg/m\\^2 IV q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m\\^2 in Cycle 5, then 100mg/m\\^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab (840 mg IV loading dose then 420mg IV q3w) and trastuzumab (8 mg/kg IV loading dose then 4mg/kg IV q3w) were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received adjuvant treatment with pertuzumab and trastuzumab IV q3w (up to 13 cycles), for a total of 17 cycles of pertuzumab and trastuzumab therapy during the study. Radiotherapy and adjuvant hormonal therapy were also given as clinically indicated. Following treatment completion/discontinuation, participants were followed for safety and efficacy for up to 5 years.","id":"OG001","title":"Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab"}],"paramType":"NUMBER","populationDescription":"Safety analysis population of all participants who received any study treatment during the neoadjuvant treatment period, grouped according to treatment received.","reportingStatus":"POSTED","timeFrame":"From day of first dose of pertuzumab or trastuzumab until the end of the neoadjuvant treatment period (as defined in the description; up to 25 weeks)","title":"Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Neoadjuvant Treatment Period","type":"PRIMARY","unitOfMeasure":"percentage of participants"}