{"classes":[{"categories":[{"measurements":[{"comment":"NA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics.\n\nIf any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as \"NC\", NC = NA","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"NA - Concentrations below the lower limit of quantitation (BLQ) are set to zero for the calculation of descriptive statistics.\n\nIf any concentration at a time point is BLQ, the geometric mean at that time point is not calculated and is presented as \"NC\", NC = NA","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"C1D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"56.6","value":"4101.40"},{"groupId":"OG001","spread":"45.3","value":"4313.38"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"C1D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"52.8","value":"12063.71"},{"groupId":"OG001","spread":"39.0","value":"15773.44"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"C1D1 - 5Hrs After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"75.8","value":"1372.33"},{"groupId":"OG001","spread":"67.1","value":"1761.02"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"C1D8 - 7 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"62.4","value":"475.30"},{"groupId":"OG001","spread":"54.1","value":"602.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C1D15 - 14 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"74.6","value":"209.06"},{"groupId":"OG001","spread":"55.4","value":"291.07"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C2D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"71.2","value":"1474.48"},{"groupId":"OG001","spread":"65.8","value":"1649.91"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"title":"C2D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64.0","value":"279.56"},{"groupId":"OG001","spread":"89.5","value":"427.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"title":"C3D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"52.6","value":"1559.93"},{"groupId":"OG001","spread":"53.1","value":"1647.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"title":"C3D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"81.4","value":"284.38"},{"groupId":"OG001","spread":"61.2","value":"494.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"48.5","value":"1448.53"},{"groupId":"OG001","spread":"54.1","value":"1404.67"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"81.3","value":"332.07"},{"groupId":"OG001","spread":"55.8","value":"578.72"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"C6D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"36.8","value":"1182.53"},{"groupId":"OG001","spread":"32.3","value":"1512.25"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"title":"C6D1 - End of Infusion"}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"description":"Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).","id":"OG000","title":"T-DXd 5.4 mg/kg Q3W"},{"description":"Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).","id":"OG001","title":"T-DXd 6.4 mg/kg Q3W"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"The PK Analysis Set included all subjects randomized/registered in Stage 1 and/or Stage 2 who received at least 1 dose of T-DXd and had measurable serum concentrations of T-DXd. Subjects were analyzed according to the treatment received","reportingStatus":"POSTED","timeFrame":"C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)","title":"Serum Concentration of Active Metabolite MAAA-1181a","type":"SECONDARY","unitOfMeasure":"pg/mL"}