{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"388.5","value":"5211.18"},{"groupId":"OG001","spread":"2058.9","value":"11934.79"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"C1D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"28.8","value":"110871.93"},{"groupId":"OG001","spread":"20.3","value":"121423.37"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"80"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"C1D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"23.4","value":"107339.74"},{"groupId":"OG001","spread":"23.0","value":"124274.05"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"},{"groupId":"OG001","value":"38"}],"units":"Participants"}],"title":"C1D1 - 5Hrs After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"40.3","value":"27646.77"},{"groupId":"OG001","spread":"49.9","value":"32741.77"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"C1D8 - 7 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"71.7","value":"10920.88"},{"groupId":"OG001","spread":"63.0","value":"14293.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C1D15 - 14 Days After Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"123.1","value":"3723.58"},{"groupId":"OG001","spread":"107.5","value":"4841.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"C2D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"66.0","value":"106755.21"},{"groupId":"OG001","spread":"23.2","value":"127427.43"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"36"}],"units":"Participants"}],"title":"C2D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"93.2","value":"6286.00"},{"groupId":"OG001","spread":"90.0","value":"9100.39"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"C3D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.8","value":"114763.30"},{"groupId":"OG001","spread":"19.5","value":"134111.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"C3D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"101.8","value":"7388.01"},{"groupId":"OG001","spread":"67.2","value":"14007.95"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"21.5","value":"113711.08"},{"groupId":"OG001","spread":"30.5","value":"133956.61"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"30"}],"units":"Participants"}],"title":"C4D1 - End of Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"94.9","value":"9033.08"},{"groupId":"OG001","spread":"73.5","value":"13535.33"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"C6D1 - Before Infusion"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"35.4","value":"104328.76"},{"groupId":"OG001","spread":"816.2","value":"37091.52"}]}],"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 Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody","type":"SECONDARY","unitOfMeasure":"ug/L"}