{"analyses":[{"ciLowerLimit":"-7.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.2","estimateComment":"The 95% CI for the difference in response (CR+PR) rates was calculated using the Anderson-Hauck continuity correction.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Difference in response rates","paramValue":"-1.64"},{"ciLowerLimit":"0.50","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.46","estimateComment":"OR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"0.86"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"84.4","upperLimit":"92.4","value":"88.8"},{"groupId":"OG001","lowerLimit":"82.5","upperLimit":"91.0","value":"87.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"260"},{"groupId":"OG001","value":"258"}],"units":"Participants"}],"description":"Tumor response was assessed using RECIST version 1.0. CR was defined as disappearance of all target lesions and short-axis reduction of any pathological lymph nodes to less than (\\<) 10 millimeters (mm) with no prior assessment of progressive disease (PD). PR was defined as greater than or equal to (≥) 30% decrease from Baseline in sum diameter (SD) of target lesions with no prior assessment of PD. PD was defined as ≥20% relative increase and ≥5 mm of absolute increase in the SD of target lesions, taking as reference the smallest SD recorded since treatment started; or appearance of 1 or more new lesions. The percentage of participants with overall response of CR or PR at the end of neoadjuvant treatment 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; only participants with measurable disease at Baseline were included.","reportingStatus":"POSTED","timeFrame":"Tumor assessments at Baseline; on Day 1 of Cycles 3, 5, 7 (cycle length of 21 days); and at time of surgery following eight cycles of Herceptin + chemotherapy (approximately 6 months overall)","title":"Percentage of Participants With Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, Among Those With Measurable Disease at Baseline","type":"SECONDARY","unitOfMeasure":"percentage of participants"}