{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.00","upperLimit":"1.84","value":"0"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"2.78","value":"0.5"}]}]}],"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.","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 study, grouped according to treatment received.","reportingStatus":"POSTED","timeFrame":"From 42 days after the last dose of study treatment until the end of treatment-free follow-up (up to 5 years)","title":"Percentage of Participants With at Least One Event of New York Heart Association (NYHA) Class III or IV Heart Failure During the Treatment-Free Follow-Up Period","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}