{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}]}],"title":"Any Adverse Event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"}]}],"title":"NCI-CTCAE Grade 3-5 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"7"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"}]}],"title":"Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Ejection Fraction Decreased (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Heart Failure (Any Grade)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"199"},{"groupId":"OG001","value":"198"}],"units":"Participants"}],"description":"An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. The terms \"severe\" and \"serious\" are not synonymous. Severity refers to the intensity of an AE (rated according to NCI-CTCAE v4.0 criteria or, if not listed, the following scale: Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to AE), and a serious AE (SAE) is a significant medical event (per standard criteria). Severity and seriousness were independently assessed for each AE. Selected AEs for reporting included heart failure (NYHA Class II/III/IV) and asymptomatic declines in LVEF (reported as ejection fraction decreased). During TFFU, only heart failure, pregnancies, and non-breast-related second primary malignancies, irrespective of causal relationship with study treatment, and drug-related SAEs were reported. Multiple occurrences of the same AE in 1 subject were counted only once.","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":"COUNT_OF_PARTICIPANTS","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 (TFFU; up to 5 years)","title":"Overview of the Number of Participants With at Least One Adverse Event During the Treatment-Free Follow-Up Period","type":"SECONDARY","unitOfMeasure":"Participants"}