{"classes":[{"categories":[{"measurements":[{"comment":"Lack of a median value is due to less than 50% of the participants experiencing the event.","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"7.4","upperLimit":"13.2","value":"9.5"},{"comment":"There were not enough events to estimate a standard error for the median survival time.","groupId":"OG002","lowerLimit":"10.6","upperLimit":"NA","value":"NA"},{"comment":"There were not enough events to estimate a standard error for the median survival time.","groupId":"OG003","lowerLimit":"10.6","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"180"},{"groupId":"OG003","value":"184"}],"units":"Participants"}],"description":"The point estimate of progression-free survival (PFS) is reported. PFS was defined as the time interval between the date of randomization/registration and the first documentation of disease progression or death due to any cause.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Progression-free survival 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":"Progression-Free Survival Estimate As Confirmed by Independent Central Review Following Intravenous Administration of DS-8201a in Participants With Metastatic Breast Cancer (Enrolled Analysis Set)","type":"SECONDARY","unitOfMeasure":"months"}