{"analyses":[{"ciLowerLimit":"1.40","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.63","estimateComment":"Ratio of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).","groupDescription":"Additional supportive analysis.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Geometric mean ratio","paramValue":"1.51"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"37.1","value":"62.1"},{"groupId":"OG001","spread":"41.9","value":"90.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"223"},{"groupId":"OG001","value":"227"}],"units":"Participants"}],"description":"Pre-dose samples were obtained after surgery (Cycle 13). The observed Ctrough was recorded, averaged among all participants, and expressed in μg/mL.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m\\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.","id":"OG000","title":"Herceptin IV + Chemotherapy"},{"description":"Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m\\^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.","id":"OG001","title":"Herceptin SC + Chemotherapy"}],"paramType":"MEAN","populationDescription":"Secondary PKPP Population: All participants with at least one measurable trastuzumab serum concentration and who did not have any major protocol violations related to PK sampling for the secondary endpoint.","reportingStatus":"POSTED","timeFrame":"Pre-dose (0 hours) on Day 1 of Cycle 13 (cycle length of 21 days)","title":"Observed Ctrough of Trastuzumab After Surgery","type":"SECONDARY","unitOfMeasure":"μg/mL"}