{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"118"},{"groupId":"OG002","value":"37"},{"groupId":"OG003","value":"18"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"184"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"21"}],"units":"Participants"}],"description":"The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Investigator-assessed objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.","groups":[{"description":"All T-DM1 resistant/refractory (R/R) participants who were treated in Part 1 or Part 2a at the recommended (5.4 mg/kg) dose.","id":"OG000","title":"Part 1 and 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":"OG001","title":"Part 1 + Part 2a + Part 2b: DS-8201a Low Dose"},{"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":"OG002","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":"OG003","title":"Part 1: DS-8201a High Dose"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Objective response rate (ORR) was assessed in the Enrolled Analysis Set at data cut-off date of 21 March 2019.","reportingStatus":"POSTED","timeFrame":"at least 6 months after last participant enrolled received first dose up to 19 months (data cut off)","title":"Objective Response Rate as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","type":"SECONDARY","unitOfMeasure":"Participants"}