{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.5"},{"groupId":"OG001","value":"4.1"}]}],"title":"Trastuzumab ADA-Positive, Baseline (n=120,121)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3.4"}]}],"title":"Trastuzumab ADA-Positive, Cycle 5 (n=114,119)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5.8"},{"groupId":"OG001","value":"7.4"}]}],"title":"rHuPH20 ADA-Positive, Baseline (n=120,121)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.6"},{"groupId":"OG001","value":"7.6"}]}],"title":"rHuPH20 ADA-Positive, Cycle 5 (n=115,119)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"122"}],"units":"Participants"}],"description":"Participants in Cohort 1 provided blood samples for immunogenicity testing to assess for anti-drug antibodies (ADAs) to trastuzumab or rHuPH20, a component of the SC Herceptin formulation. The percentage of participants who were trastuzumab ADA-positive and the percentage of participants who were rHuPH20 ADA-positive were each reported.","groups":[{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.","id":"OG000","title":"Cohort 1: SC (SID) Then IV Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.","id":"OG001","title":"Cohort 1: IV Then SC (SID) Herceptin"}],"paramType":"NUMBER","populationDescription":"Safety Population. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate immunogenicity within participants who received the SID formulation of Herceptin. The number of participants who provided ADA samples at each timepoint (n) is shown in the table.","reportingStatus":"POSTED","timeFrame":"Baseline, pre-dose (0 hours) during Cycle 5 (cycle length of 3 weeks)","title":"Percentage of Participants With Anti-Trastuzumab or Anti-Recombinant Human Hyaluronidase (rHuPH20) Antibodies","type":"SECONDARY","unitOfMeasure":"percentage of participants"}