{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"113"},{"groupId":"OG001","value":"122"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"92"}]}],"title":"Any Adverse Event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"AE with Fatal Outcome"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Related AE with Fatal Outcome"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"7"}]}],"title":"Grade 3 to 5 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Related Grade 3 to 5 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}],"title":"Cardiac AE (Including LVEF Events)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"4"}]}],"title":"Serious AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}],"title":"Anaphylaxis and Hypersensitivity AE, All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Anaphylaxis and Hypersensitivity AE, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"38"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"16"}]}],"title":"Administration Related Reaction AE, All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Administration Related Reaction AE, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}],"title":"Cardiac Dysfunction AE, All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Cardiac Dysfunction AE, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Diarrhea Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Rash/Skin Reactions"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Mucositis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"13"}]}],"title":"Pulmonary Events (ARR), All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Pulmonary Events (ARR), Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Pregnancy and Neonatal Related AEs, All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Pregnancy and Neonatal Related AEs, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Interstitial Lung Disease (ILD), All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Interstitial Lung Disease (ILD), Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"5"}]}],"title":"Neutropenia/Febrile Neutropenia, All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}],"title":"Neutropenia/Febrile Neutropenia, Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"Local Infusion Site Reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"Systemic Infusion Site Reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"13"}]}],"title":"Local Injection Site Reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}],"title":"Systemic Injection Site Reaction"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"AE Leading to Any Study Treatment Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}],"title":"AE Leading to PH FDC SC Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"AE Leading to Pertuzumab IV Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}],"title":"AE Leading to Trastuzumab IV Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"8"}]}],"title":"AE Leading to Any Study Treatment Interruption or Dose Reduction"}],"denoms":[{"counts":[{"groupId":"OG000","value":"160"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"138"}],"units":"Participants"}],"description":"Investigators used the NCI CTCAE v4.0 grading scale for assessing adverse event (AE) severity; if not listed, AE severity was graded as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe or medically significant; Grade 4 = life-threatening; Grade 5 = death related to AE. Severity and seriousness are not synonymous and investigators independently assessed these criteria for each AE. Investigators also determined whether an AE was considered to be related to the study drug. Adverse events to monitor were defined based on known risks associated with the study drugs and included: hypersensitivity reactions, administration-related reactions (ARRs), cardiac dysfunction, diarrhea grade ≥3, rash/skin reactions, mucositis, interstitial lung disease (ILD), (febrile) neutropenia, pulmonary events that may occur as a result of an ARR, and pregnancy/neonatal related. Multiple occurrences of AEs were counted only once per participant. LVEF = left ventricular ejection fraction","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":"From Day 1 of Cycle 1 to end of Cycle 6 of the Treatment Cross-Over Period; from Day 1 of Cycle 7 up to the completion of 18 cycles of neo/adjuvant anti-HER2 treatment in the Treatment Continuation Period (1 cycle is 21 days)","title":"Safety Summary of the FDC SC and IV Formulations: Number of Participants With at Least One Adverse Event During the Treatment Cross-Over and Treatment Continuation Periods","type":"SECONDARY","unitOfMeasure":"Participants"}