{"classes":[{"categories":[{"measurements":[{"comment":"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":"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":"27.5","value":"118452.77"},{"groupId":"OG001","spread":"18.1","value":"134613.79"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"C1D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.0","value":"123433.28"},{"groupId":"OG001","spread":"19.8","value":"142399.71"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"C1D1 - 5Hrs After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"38.9","value":"22261.67"},{"groupId":"OG001","spread":"51.5","value":"28142.80"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"C1D8 - 7 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"61.7","value":"8092.08"},{"groupId":"OG001","spread":"60.3","value":"11396.97"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C1D15 - 14 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"118.8","value":"2827.01"},{"groupId":"OG001","spread":"73.0","value":"4420.63"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C2D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"67.2","value":"109777.43"},{"groupId":"OG001","spread":"22.2","value":"135637.46"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"title":"C2D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"83.6","value":"4823.41"},{"groupId":"OG001","spread":"74.3","value":"7543.17"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"C3D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.8","value":"122218.96"},{"groupId":"OG001","spread":"24.7","value":"139264.52"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"C3D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"89.5","value":"5846.34"},{"groupId":"OG001","spread":"51.8","value":"11013.81"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.4","value":"124240.37"},{"groupId":"OG001","spread":"30.3","value":"134129.68"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"74.5","value":"7507.28"},{"groupId":"OG001","spread":"59.0","value":"10793.89"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"C6D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"25.3","value":"117769.64"},{"groupId":"OG001","spread":"1079.6","value":"35753.88"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}],"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 T-DXd","type":"SECONDARY","unitOfMeasure":"ug/L"}