{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"150","value":"611"},{"groupId":"OG001","spread":"143","value":"572"},{"groupId":"OG002","spread":"160","value":"545"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"AUClast: DS-8201a, Cycle 1"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"AUClast: DS-8201a, Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"241","value":"667"},{"groupId":"OG001","spread":"126","value":"570"},{"groupId":"OG002","spread":"167","value":"547"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"title":"AUClast: Total Anti-HER2 antibody, Cycle 1"},{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"AUClast: Total Anti-HER2 antibody, Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"150","value":"612"},{"groupId":"OG001","spread":"143","value":"572"},{"groupId":"OG002","spread":"114","value":"569"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"23"}],"units":"Participants"}],"title":"AUC21d: DS-8201a, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"213","value":"867"},{"groupId":"OG001","spread":"197","value":"746"},{"groupId":"OG002","spread":"71.9","value":"724"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"10"}],"units":"Participants"}],"title":"AUC21d: DS-8201a, Cycle 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"210","value":"651"},{"groupId":"OG001","spread":"126","value":"570"},{"groupId":"OG002","spread":"104","value":"582"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"22"}],"units":"Participants"}],"title":"AUC21d: Total Anti-HER2 antibody, Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"244","value":"888"},{"groupId":"OG001","spread":"210","value":"775"},{"groupId":"OG002","spread":"110","value":"737"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"9"}],"units":"Participants"}],"title":"AUC21d: Total Anti-HER2 antibody, Cycle 3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"125"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"}],"units":"Participants"}],"description":"Blood samples for DS-8201a pharmacokinetic (PK) analysis were obtained at the specified timepoints. Area under the concentration versus time curve (AUC) from Time 0 to the Last Quantifiable Concentration (AUClast) and Area Under the Concentration versus-Time Curve up to 21 days (AUC21d) are reported. These serum PK parameters for DS-8201a and total anti-HER2 antibody were estimated in each participant using standard noncompartmental methods.","dispersionType":"Standard Deviation","groups":[{"description":"Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.","id":"OG000","title":"DS-8201a"},{"description":"Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.","id":"OG001","title":"Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a"},{"description":"Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.","id":"OG002","title":"Exploratory: Naïve HER2 IHC 1+, DS-8201a"}],"paramType":"MEAN","populationDescription":"Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. No patient samples were collected or analyzed for AUClast DS-8201a and total anti-HER2 antibody for Cycle 3 as AUClast was planned to be assessed only for Cycle 1.","reportingStatus":"POSTED","timeFrame":"Cycle 1 and 3, Day 1: predose, 4 hours (h), 7h postdose; Day 8, Day 15, and Day 22 postdose; Cycle 2, Day 1 and Day 22 postdose; Cycle 4, 6, and 8, Day 1 postdose (each cycle is 21 days)","title":"Pharmacokinetic Parameters of Area Under the Concentration Versus-Time Curve of DS-8201a and Total Anti-HER2 Antibody Following Treatment With DS-8201a","type":"SECONDARY","unitOfMeasure":"ug*d/mL"}