{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"138"}],"units":"Participants"}],"description":"Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. All participants who enrolled in this study must have had a baseline LVEF ≥55%. Verbatim description of adverse events was mapped to Medical Dictionary for Regulatory Activities (MedDRA) version 25.1. The MedDRA preferred term of 'ejection fraction decreased' is defined as an LVEF decrease of at least 10 percentage points from baseline and to below 50%.","groups":[{"description":"This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.","id":"OG000","title":"P+H IV: Treatment Cross-Over Period"},{"description":"This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Cross-Over Period of the study.","id":"OG001","title":"PH FDC SC: Treatment Cross-Over Period"},{"description":"This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).","id":"OG002","title":"P+H IV: Treatment Continuation Period"},{"description":"This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination administered subcutaneously (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).","id":"OG003","title":"PH FDC SC: Treatment Continuation Period"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population: All participants who received at least one dose of any study treatment categorized according to the study treatment administered. In this analysis, participants are grouped by treatment received during the Cross-Over and Continuation Periods.","reportingStatus":"POSTED","timeFrame":"Baseline; Day 1 of Cycles 4, 7, and 11 (each cycle is 21 days); End of Treatment Visit (up to 1 year)","title":"Number of Participants With at Least One Event of Ejection Fraction Decreased With the FDC SC and IV Formulations During the Treatment Cross-Over and Treatment Continuation Periods","type":"SECONDARY","unitOfMeasure":"Participants"}