{"denoms":[{"counts":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"114"}],"units":"Participants"}],"groups":[{"description":"Non-randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.","id":"BG000","title":"Tucatinib+Trastuzumab (Cohort A)"},{"description":"Randomized cohort. Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Trastuzumab 8 mg/kg by IV infusion on Day 1 of Cycle 1 and 6 mg/kg on Day 1 of each subsequent cycle until PD, death, withdrawal of consent, study closure, or alternative therapy.","id":"BG001","title":"Tucatinib+Trastuzumab (Cohort B)"},{"description":"Participants received Tucatinib 300 mg PO BID on Days 1 to 21 of each 21-day cycle. Participants who did not respond to monotherapy were given the option to receive tucatinib and trastuzumab until PD, death, withdrawal of consent, study closure, or alternative therapy based on radiographic progression (as determined by investigator assessment using RECIST v1.1), or if they had not achieved a PR or CR by the week 12 assessment.","id":"BG002","title":"Tucatinib Monotherapy (Cohort C)"},{"description":"Total of all reporting groups","id":"BG003","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"24","upperLimit":"71","value":"52"},{"groupId":"BG001","lowerLimit":"31","upperLimit":"77","value":"57"},{"groupId":"BG002","lowerLimit":"29","upperLimit":"75","value":"59.5"},{"groupId":"BG003","lowerLimit":"24","upperLimit":"77","value":"56"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"48"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"26"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"66"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"35"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"89"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"21"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"6"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"37"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"23"},{"groupId":"BG003","value":"88"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"15"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"67"}],"title":"Grade 0"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"44"}],"title":"Grade 1"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"}],"title":"Grade 2"}]}],"description":"ECOG performance status was used to assess participants disease progression, and ability to carry out daily living activities. 0=Normal activity; 1=Symptoms but ambulatory; 2=In bed less than (\\<)50 percent (%) of the time; 3= In bed \\>50% of the time; 4=100% bedridden; 5=Dead.","paramType":"COUNT_OF_PARTICIPANTS","title":"Eastern Cooperative Oncology Group (ECOG) Performance Status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"24"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"85"}],"title":"North America"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"14"},{"groupId":"BG003","value":"29"}],"title":"Europe"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"}],"populationDescription":"The Full Analysis Set included all participants who were enrolled and received any amount of study treatment and had human epidermal growth factor receptor 2+ (HER2+) tumors as defined by one or more protocol required local tests."}