{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}]}],"title":"Any Primary Cardiac Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Heart Failure and Significant LVEF Decline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Cardiac Death (Definite or Probable)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"248"}],"units":"Participants"}],"description":"A primary cardiac event is defined as the occurrence of either of the following events: - Incidence of a symptomatic ejection fraction decrease (heart failure) of New York Heart Association (NYHA) Class III or IV and a drop in left ventricular ejection fraction (LVEF) of at least 10-percentage points from baseline and to below 50%; or - Cardiac death, defined as: Definite cardiac death (due to heart failure, myocardial infarction, or documented primary arrhythmia); or, Probable cardiac death (sudden unexpected death within 24 hours of a definite or probable cardiac event \\[e.g., syncope, cardiac arrest, chest pain, infarction, arrhythmia\\] without documented etiology).","groups":[{"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \\[G-CSF\\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.","id":"OG000","title":"Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy"},{"description":"Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.","id":"OG001","title":"Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population: includes all participants who received at least one dose of study medication.","reportingStatus":"POSTED","timeFrame":"From first dose of study treatment until the completion of neoadjuvant therapy (24 weeks)","title":"Number of Participants With a Primary Cardiac Event During the Neoadjuvant Phase","type":"SECONDARY","unitOfMeasure":"Participants"}