{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"18.3","value":"-26.2"},{"groupId":"OG001","spread":"25.4","value":"-32.9"},{"groupId":"OG002","spread":"21.6","value":"-26.9"},{"groupId":"OG003","spread":"22.5","value":"-26.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"164"},{"groupId":"OG003","value":"167"}],"units":"Participants"}],"title":"Baseline to Week 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.7","value":"-39.6"},{"groupId":"OG001","spread":"28.1","value":"-43.6"},{"groupId":"OG002","spread":"24.5","value":"-39.9"},{"groupId":"OG003","spread":"24.9","value":"-40.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"152"},{"groupId":"OG003","value":"154"}],"units":"Participants"}],"title":"Baseline to Week 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.1","value":"-50.1"},{"groupId":"OG001","spread":"29.4","value":"-58.5"},{"groupId":"OG002","spread":"27.8","value":"-44.4"},{"groupId":"OG003","spread":"28.0","value":"-44.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"136"},{"groupId":"OG003","value":"138"}],"units":"Participants"}],"title":"Baseline to Week 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.1","value":"-56.3"},{"groupId":"OG001","spread":"32.0","value":"-61.9"},{"groupId":"OG002","spread":"30.6","value":"-49.2"},{"groupId":"OG003","spread":"30.5","value":"-49.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"124"},{"groupId":"OG003","value":"125"}],"units":"Participants"}],"title":"Baseline to Week 24"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.1","value":"-59.1"},{"groupId":"OG001","spread":"32.2","value":"-63.9"},{"groupId":"OG002","spread":"29.2","value":"-51.2"},{"groupId":"OG003","spread":"29.2","value":"-51.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"80"},{"groupId":"OG003","value":"81"}],"units":"Participants"}],"title":"Baseline to Week 30"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.7","value":"-61.0"},{"groupId":"OG001","spread":"32.2","value":"-54.6"},{"groupId":"OG002","spread":"29.9","value":"-55.5"},{"groupId":"OG003","spread":"29.9","value":"-55.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"46"}],"units":"Participants"}],"title":"Baseline to Week 36"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.2","value":"-59.5"},{"groupId":"OG001","spread":"27.7","value":"-65.3"},{"groupId":"OG002","spread":"28.3","value":"-50.5"},{"groupId":"OG003","spread":"28.8","value":"-50.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"166"},{"groupId":"OG003","value":"169"}],"units":"Participants"}],"title":"Best percent change from baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"180"},{"groupId":"OG003","value":"184"}],"units":"Participants"}],"description":"Best percent change in sum of diameters of measurable tumors was based on RECIST 1.1. The best percent change was defined as the percent change in the smallest sum of diameters from all post-baseline tumor assessments, taking as reference the baseline sum of diameters.","dispersionType":"Standard Deviation","groups":[{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG000","title":"Part 1: DS-8201a Medium Dose"},{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"OG001","title":"Part 1: DS-8201a High Dose"},{"description":"All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 1 or Part 2a.","id":"OG002","title":"Part 1 + Part 2a: DS-8201a Low Dose"},{"description":"All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 1 or Part 2a or Part 2b.","id":"OG003","title":"Part 1 + Part 2a + Part 2b: DS-8201a Low Dose"}],"paramType":"MEAN","populationDescription":"Best percent change from baseline in sum of diameters was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.","reportingStatus":"POSTED","timeFrame":"Baseline up to Week 6, 12, 18, 24, 30, 36 post dose","title":"Percent Change From Baseline in Sum of Diameters Over Time as Determined by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","type":"SECONDARY","unitOfMeasure":"Percent change from baseline"}