{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"248"}]}],"title":"Any Adverse Event (AE): Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"}]}],"title":"AE with Fatal Outcome (Grade 5)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"132"}]}],"title":"Any AE: Grades 3 to 5"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"49"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"29"}]}],"title":"Related Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"Anaphylaxis and Hypersensitivity AEs, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Anaphylaxis and Hypersensitivity AEs, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"54"}]}],"title":"Infusion/Admin.-Related Reactions Within 24 hrs, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"}]}],"title":"Infusion/Admin.-Related Reactions Within 24 hrs, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Serious Rash/Skin Reactions, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Serious Rash/Skin Reactions, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"149"},{"groupId":"OG001","value":"153"}]}],"title":"Diarrhoea, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"16"}]}],"title":"Diarrhoea, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"52"}]}],"title":"Cardiac Dysfunction, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"3"}]}],"title":"Cardiac Dysfunction, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"}]}],"title":"Interstitial Lung Disease, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Interstitial Lung Disease, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"142"},{"groupId":"OG001","value":"123"}]}],"title":"Neutropenia/Febrile Neutropenia, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"82"}]}],"title":"Neutropenia/Febrile Neutropenia, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}],"title":"Serious Mucositis, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}]}],"title":"Serious Mucositis, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}],"title":"Pregnancy- and Neonatal-Related AEs, Any Grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"22"}]}],"title":"AE Leading to Study Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"12"}]}],"title":"AE Leading to HER2-Targeted Therapy Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"14"}]}],"title":"AE Leading to Any Chemotherapy Drug Discontinuation"}],"denoms":[{"counts":[{"groupId":"OG000","value":"252"},{"groupId":"OG001","value":"248"}],"units":"Participants"}],"description":"The adverse event (AE) severity grading scale for the NCI CTCAE v4.0 was used for assessing AE severity. Any AEs that were not specifically listed in the NCI CTCAE, v4.0 were graded per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. The terms \"severe\" and \"serious\" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.","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 28 days after last dose of study treatment (up to 1 year, 6 months)","title":"Summary of the Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0), Over the Course of the Entire Study","type":"SECONDARY","unitOfMeasure":"Participants"}