{"analyses":[{"ciLowerLimit":"-3.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.5","estimateComment":"The 95% CI for the difference in response (tpCR) rates was calculated using the Anderson-Hauck continuity correction.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Difference in response rates","paramValue":"5.01"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"28.5","upperLimit":"40.3","value":"34.2"},{"groupId":"OG001","lowerLimit":"33.3","upperLimit":"45.5","value":"39.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"260"}],"units":"Participants"}],"description":"Participants were evaluated following eight cycles of treatment and after surgery to assess for tpCR, defined as absence of neoplastic invasive cells in the breast and axillary lymph nodes according to pathologist examination. The percentage of participants with tpCR was reported, and the 95% CI for one-sample binomial was constructed using the Pearson-Clopper method.","dispersionType":"95% Confidence Interval","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 Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could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":"NUMBER","populationDescription":"EPP Population","reportingStatus":"POSTED","timeFrame":"After surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months from Baseline)","title":"Percentage of Participants With Total Pathological Complete Response (tpCR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}