{"classes":[{"categories":[{"measurements":[{"comment":"The geometric mean and geometric coefficient of variation were not estimable as the samples were below the limit of quantification. The samples were taken prior to administration of the first dose.","groupId":"OG000","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"390"}],"units":"Participants"}],"title":"Pre-infusion on Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"154.7","value":"71.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"418"}],"units":"Participants"}],"title":"15-30 minutes post-infusion on Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"74.3","value":"81.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"}],"units":"Participants"}],"title":"2 hours post-infusion on Cycle 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"256.8","value":"7.93"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"}],"units":"Participants"}],"title":"Pre-infusion on Cycle 2"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"78.0","value":"13.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"391"}],"units":"Participants"}],"title":"Pre-infusion on Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"46.5","value":"76.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"361"}],"units":"Participants"}],"title":"15-30 minutes post-infusion on Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.0","value":"81.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"37"}],"units":"Participants"}],"title":"2 hours post-infusion on Cycle 4"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"125.0","value":"8.90"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"}],"units":"Participants"}],"title":"Pre-infusion on Cycle 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"421"}],"units":"Participants"}],"description":"Total trastuzumab is the sum of conjugated and unconjugated trastuzumab. Blood and serum samples were obtained from participants randomized to the trastuzumab arm.","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"OG000","title":"Trastuzumab"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK-evaluable population included all participants who received at least 1 dose of trastuzumab and had at least one evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.","reportingStatus":"POSTED","timeFrame":"Pre-infusion on Day 1 of Cycles 1, 2, 4, and 5; 15-30 minutes and 2 hours post-infusion on Day 1 of Cycles 1 and 4 (1 cycle = 21 days)","title":"Serum Concentrations of Total Trastuzumab","type":"SECONDARY","unitOfMeasure":"ug/mL"}