{"denoms":[{"counts":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"130"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"253"}],"units":"Participants"}],"groups":[{"description":"T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.","id":"BG000","title":"Part 1: 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":"BG001","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":"BG002","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 2a in the continuation phase.","id":"BG003","title":"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 2b in the continuation phase.","id":"BG004","title":"Part 2b (Exploratory): DS-8201a Low Dose"},{"description":"Total of all reporting groups","id":"BG005","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"101"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"189"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"29"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"64"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"11.3","value":"57.9"},{"groupId":"BG001","spread":"13.0","value":"55.8"},{"groupId":"BG002","spread":"10.5","value":"54.4"},{"groupId":"BG003","spread":"11.9","value":"55.4"},{"groupId":"BG004","spread":"9.2","value":"49.8"},{"groupId":"BG005","spread":"11.8","value":"55.8"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"130"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"253"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"2"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"47"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"104"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"5"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"76"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"132"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"4"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"5"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"25"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"40"}]}],"title":"South Korea"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"9"}]}],"title":"Belgium"},{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"36"},{"groupId":"BG004","value":"2"},{"groupId":"BG005","value":"77"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"16"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"14"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"56"}]}],"title":"Japan"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"10"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"12"}]}],"title":"United Kingdom"},{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"17"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"20"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"29"}]}],"title":"Spain"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}