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High"}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"80"},{"groupId":"OG004","value":"21"},{"groupId":"OG005","value":"138"}],"units":"Participants"}],"description":"The number of participants at any post-baseline timepoint with abnormal readings outside the normal range for vital signs of diastolic and systolic blood pressure, pulse rate, respiratory rate, and body temperature were summarized according the specified direction of the abnormal reading (high or low). The number analyzed (denominator) in the results table represents participants without the specified abnormal vital sign at baseline. Not every vital sign abnormality qualified as an adverse event (AE). A vital sign result must have been reported as an AE if it met any of the following criteria: was accompanied by clinical symptoms; resulted in a change in study treatment (e.g., dosage modification, treatment interruption, or treatment discontinuation); resulted in a medical intervention or a change in concomitant therapy; or, was clinically significant in the investigator's judgment.","groups":[{"description":"This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 1 to 3 when all Arm A participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).","id":"OG000","title":"Arm A: Treatment With P+H IV (Cycles 1 to 3)"},{"description":"This safety analysis population only includes the safety data that was collected from Arm A participants during treatment Cycles 4 to 6 when all Arm A participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles and that was followed by treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days).","id":"OG001","title":"Arm A: Treatment With PH FDC SC (Cycles 4 to 6)"},{"description":"This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 1 to 3 when all Arm B participants were treated with PH FDC SC. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).","id":"OG002","title":"Arm B: Treatment With PH FDC SC (Cycles 1 to 3)"},{"description":"This safety analysis population only includes the safety data that was collected from Arm B participants during treatment Cycles 4 to 6 when all Arm B participants were treated with P+H IV. In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received treatment with pertuzumab and trastuzumab FDC SC (PH FDC SC) for 3 treatment cycles and that was followed by treatment with pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles (1 cycle = 21 days).","id":"OG003","title":"Arm B: Treatment With P+H IV (Cycles 4 to 6)"},{"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":"OG004","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":"OG005","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 study arm and treatment received during the Cross-Over Period, and only by treatment received during the Continuation Period. The number analyzed (denominator) represents those without an abnormality at baseline.","reportingStatus":"POSTED","timeFrame":"Pre-dose at Day 1 of Cycles 1 (baseline), 4, and 7, and end of treatment (up to 18 cycles; 1 cycle is 21 days)","title":"Number of Participants With Targeted Vital Signs Outside the Normal Limits Among Those Without an Abnormality at Baseline During the Treatment Cross-Over and Treatment Continuation Periods","type":"SECONDARY","unitOfMeasure":"Participants"}