{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"13.1","value":"51.7"},{"groupId":"OG001","spread":"58.7","value":"116"},{"groupId":"OG002","spread":"142","value":"325"},{"groupId":"OG003","spread":"165","value":"544"},{"groupId":"OG004","spread":"155","value":"901"},{"groupId":"OG005","spread":"229","value":"996"},{"groupId":"OG006","spread":"178","value":"559"},{"groupId":"OG007","spread":"228","value":"785"},{"groupId":"OG008","spread":"180","value":"581"},{"groupId":"OG009","spread":"178","value":"693"},{"groupId":"OG010","spread":"163","value":"542"},{"groupId":"OG011","spread":"126","value":"507"},{"groupId":"OG012","spread":"184","value":"631"},{"groupId":"OG013","spread":"102","value":"693"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"48"},{"groupId":"OG007","value":"50"},{"groupId":"OG008","value":"20"},{"groupId":"OG009","value":"19"},{"groupId":"OG010","value":"17"},{"groupId":"OG011","value":"23"},{"groupId":"OG012","value":"58"},{"groupId":"OG013","value":"21"}],"units":"Participants"}],"title":"AUClast"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.9","value":"55.0"},{"groupId":"OG001","spread":"58.9","value":"121"},{"groupId":"OG002","spread":"150","value":"340"},{"groupId":"OG003","spread":"186","value":"590"},{"groupId":"OG004","spread":"209","value":"1030"},{"groupId":"OG005","spread":"259","value":"1100"},{"groupId":"OG006","spread":"203","value":"602"},{"groupId":"OG007","spread":"243","value":"848"},{"groupId":"OG008","spread":"145","value":"589"},{"groupId":"OG009","spread":"205","value":"762"},{"groupId":"OG010","spread":"183","value":"596"},{"groupId":"OG011","spread":"151","value":"563"},{"groupId":"OG012","spread":"209","value":"683"},{"groupId":"OG013","spread":"118","value":"753"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"48"},{"groupId":"OG007","value":"49"},{"groupId":"OG008","value":"19"},{"groupId":"OG009","value":"17"},{"groupId":"OG010","value":"17"},{"groupId":"OG011","value":"22"},{"groupId":"OG012","value":"58"},{"groupId":"OG013","value":"21"}],"units":"Participants"}],"title":"AUCinfinity"}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"5"},{"groupId":"OG006","value":"48"},{"groupId":"OG007","value":"50"},{"groupId":"OG008","value":"20"},{"groupId":"OG009","value":"19"},{"groupId":"OG010","value":"17"},{"groupId":"OG011","value":"23"},{"groupId":"OG012","value":"58"},{"groupId":"OG013","value":"21"}],"units":"Participants"}],"description":"The serum PK parameters of DS-8201a and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods.","dispersionType":"Standard Deviation","groups":[{"description":"Participants in Cohort 1 received an intravenous 0.8 mg/kg dose of DS-8201a (FL-DP1).","id":"OG000","title":"Dose Escalation: Cohort 1, 0.8 mg/kg"},{"description":"Participants in Cohort 2 received an intravenous 1.6 mg/kg dose of DS-8201a (FL-DP1).","id":"OG001","title":"Dose Escalation: Cohort 2, 1.6 mg/kg"},{"description":"Participants in Cohort 3 received an intravenous 3.2 mg/kg dose of DS-8201a (FL-DP1).","id":"OG002","title":"Dose Escalation: Cohort 3, 3.2 mg/kg"},{"description":"Participants in Cohort 4 received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG003","title":"Dose Escalation: Cohort 4, 5.4 mg/kg"},{"description":"Participants in Cohort 5 received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG004","title":"Dose Escalation: Cohort 5, 6.4 mg/kg"},{"description":"Participants in Cohort 6 received an intravenous 8.0 mg/kg dose of DS-8201a (FL-DP1).","id":"OG005","title":"Dose Escalation: Cohort 6, 8.0 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG006","title":"Dose Expansion: HER2-positive Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG007","title":"Dose Expansion: HER2-positive Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 5.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG008","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 5.4 mg/kg"},{"description":"Participants with HER2-low expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG009","title":"Dose Expansion: HER2-low Expressing Breast Cancer, 6.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG010","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 5.4 mg/kg"},{"description":"Participants with HER2-overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG011","title":"Dose Expansion: HER2-overexpressing Gastric or GEJ, 6.4 mg/kg"},{"description":"Participants with any other HER2-expressing solid tumor other than breast or gastric or any tumor with HER2 mutation received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP1).","id":"OG012","title":"Dose Expansion: HER2-expressing Other Solid Tumors"},{"description":"Japan only: Participants with HER2-expressing breast cancer received an intravenous 6.4 mg/kg dose of DS-8201a (FL-DP2).","id":"OG013","title":"Dose Expansion: HER2-expressing Breast Cancer"}],"paramType":"MEAN","populationDescription":"Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.","reportingStatus":"POSTED","timeFrame":"Post first dose up to Day 147","title":"Pharmacokinetic (PK) Analysis: Area Under the Concentration Versus Time Curve (AUC) of Serum DS-8201a Following First Dose","type":"SECONDARY","unitOfMeasure":"ug*d/mL"}