{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"180.04","value":"151.83"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"166"}],"units":"Participants"}],"title":"Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"144.77","value":"158.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"}],"units":"Participants"}],"title":"Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"192.19","value":"137.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"166"}],"units":"Participants"}],"title":"Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"180.92","value":"155.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"177"}],"units":"Participants"}],"title":"Cycle 5"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"215.17","value":"146.03"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"183"}],"units":"Participants"}],"title":"Cycle 6"}],"denoms":[{"counts":[{"groupId":"OG000","value":"321"}],"units":"Participants"}],"description":"Concentration at Trough was defined as predose/trough concentration observed directly from data.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants with locally advanced HER2+/ mBC were allocated to receive tucatinib 300 mg PO BID with trastuzumab 6 mg/kg IV or at a fixed dose of 600 mg SC, and pertuzumab 420 mg IV once every 21 days. Participants may also have received a fixed dose combination of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units hyaluronidase SC, once every 21 days. Participants received study treatment until unacceptable toxicity, disease progression, withdrawal of consent, or study closure.","id":"OG000","title":"Tucatinib + Trastuzumab + Pertuzumab"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK analysis set included all randomized participants who received at least one dose of tucatinib and had at least one evaluable PK assessment. Results were not reported for placebo+Trastuzumab+Pertuzumab arm as more than 50% of concentrations were below the lower limit of quantification(as expected) as prespecified in statistical analysis plan. Overall number of participants analyzed=participants evaluable for this outcome measure. Number Analyzed=participants evaluable for specified rows.","reportingStatus":"POSTED","timeFrame":"Pre-dose on Day 1 of Cycles 2, 3, 4, 5 and 6","title":"Trough Concentration (Ctrough) of Tucatinib","type":"SECONDARY","unitOfMeasure":"nanograms per milliliter"}