{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"49"}]}],"title":"Treatment-induced ADA"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"}]}],"title":"Treatment-enhanced ADA"}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"}],"units":"Participants"}],"description":"Participants in the Herceptin SC arm provided PK samples for evaluation of anti-rHuPH20 antibodies. The number of participants with \"Treatment-induced ADAs\" and \"Treatment-enhanced ADA\" against rHuPH20 (an excipient unique to the SC formulation) at any time during or after treatment was reported. Treatment-induced ADA = a participant with negative or missing Baseline ADA result(s) and at least one positive post-Baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at Baseline who has one or more post Baseline titer results that are at least 0.60 titer unit greater than the Baseline titer result (four-fold increase of titer).","groups":[{"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 Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could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":"OG000","title":"Herceptin SC + Chemotherapy"}],"paramType":"NUMBER","populationDescription":"Safety Population; as rHuPH20 is unique to SC formulation, this outcome measure was applicable for \"Herceptin SC + Chemotherapy\" arm only. Here, Overall Number of Participants Analyzed = participants who were evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Baseline; pre-dose (0 hours) on Day 1 of Cycles 2, 5, 13, 18 (cycle length of 21 days); and Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 from last dose of Cycle 18","title":"Number of Participants With ADAs Against Recombinant Human Hyaluronidase (rHuPH20)","type":"SECONDARY","unitOfMeasure":"participants"}