{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"6"}]}],"title":"Complete response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"112"},{"groupId":"OG003","value":"112"}]}],"title":"Partial response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"59"},{"groupId":"OG003","value":"61"}]}],"title":"Stable disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"}]}],"title":"Progressive disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}],"title":"Non-evaluable"}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"180"},{"groupId":"OG003","value":"184"}],"units":"Participants"}],"description":"Best overall tumor response was defined as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) by the investigator based on RECIST v1.1. Participants who were non-evaluable (NE) are also reported.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Best overall tumor response 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":"Best Overall Tumor Response as Confirmed By the Investigator Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","type":"SECONDARY","unitOfMeasure":"Participants"}