{"classes":[{"categories":[{"measurements":[{"comment":"NA indicated that mean and standard deviation (SD) were not estimable as the values were below the lower limit of quantification (LLOQ). LLOQ was 0.4 mcg/mL.","groupId":"OG000","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"title":"T-DXd: Day 1: pre-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.958729","value":"4.35225"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"402"}],"units":"Participants"}],"title":"T-DXd: Day 1: pre-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"9.464435","value":"8.21037"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"374"}],"units":"Participants"}],"title":"T-DXd: Day 1: pre-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.753592","value":"8.65950"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"336"}],"units":"Participants"}],"title":"T-DXd: Day 1: pre-dose, Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"22.894112","value":"11.31496"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"304"}],"units":"Participants"}],"title":"T-DXd: Day 1: pre-dose, Cycle 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"102.989325","value":"135.90160"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"367"}],"units":"Participants"}],"title":"T-DXd: Day 1: 15 minutes post-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"108.860006","value":"136.74872"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"378"}],"units":"Participants"}],"title":"T-DXd: Day 1: 15 minutes post-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"39.812165","value":"124.60481"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"347"}],"units":"Participants"}],"title":"T-DXd: Day 1: 15 minutes post-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"30.513998","value":"123.82288"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"366"}],"units":"Participants"}],"title":"T-DXd: Day 1: 5 hours post-dose, Cycle 1"},{"categories":[{"measurements":[{"comment":"NA indicated that mean and SD were not estimable as the values were below the LLOQ. LLOQ was 0.4 mcg/mL.","groupId":"OG000","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: pre-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.351915","value":"5.75841"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"390"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: pre-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.087226","value":"12.00513"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"370"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: pre-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"8.720790","value":"13.97891"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"333"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: pre-dose, Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"27.144299","value":"17.47641"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"302"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: pre-dose, Cycle 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"114.137606","value":"141.27586"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"367"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: 15 minutes post-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"134.780719","value":"146.17993"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"377"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: 15 minutes post-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"44.228380","value":"131.06830"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"345"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: 15 minutes post-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"26.591288","value":"119.64619"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"363"}],"units":"Participants"}],"title":"Total anti-HER2 antibody: Day 1: 5 hours post-dose, Cycle 1"},{"categories":[{"measurements":[{"comment":"NA indicated that mean and SD were not estimable as the values were below the LLOQ. LLOQ was 0.00001 mcg/mL.","groupId":"OG000","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: pre-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2096642","value":"0.261850"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"407"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: pre-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2825761","value":"0.401004"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"380"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: pre-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2957478","value":"0.446237"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"336"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: pre-dose, Cycle 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2819292","value":"0.432894"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"307"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: pre-dose, Cycle 8"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.1859583","value":"6.014366"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"367"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: 15 minutes post-dose, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.9276120","value":"2.985606"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"376"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: 15 minutes post-dose, Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.5862547","value":"2.411409"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"348"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: 15 minutes post-dose, Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.5178612","value":"13.917874"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"363"}],"units":"Participants"}],"title":"MAAA-1181a: Day 1: 5 hours post-dose, Cycle 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"407"}],"units":"Participants"}],"description":"Blood samples were collected at indicated time points to determine the concentration of T-DXd, total anti-HER2 antibody and MAAA-1181a in serum.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received T-DXd 5.4 mg/kg via IV infusion every 3 weeks until PD, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation was met.","id":"OG000","title":"T-DXd"}],"paramType":"MEAN","populationDescription":"The Pharmacokinetic population included all participants who received at least 1 dose of T-DXd per the protocol for whom any post-dose data were available. Only participants with data collected in specified timepoints are reported.","reportingStatus":"POSTED","timeFrame":"Pre-dose on Day 1 of Cycles 1, 2, 4, 6 and 8; 15 minutes post-dose on Day 1 of Cycles 1, 2 and 4; and 5 hours post-dose on Day 1 of Cycle 1 (each cycle is 21 days)","title":"Serum Concentration of Trastuzumab Deruxtecan (T-DXd), Total Anti-Human Epidermal Growth Factor Receptor 2 Antibody and MAAA-1181a","type":"SECONDARY","unitOfMeasure":"micrograms per milliliter (mcg/mL)"}