{"analyses":[{"ciLowerLimit":"0.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.29","estimateComment":"HR of test treatment group (Herceptin SC + Chemotherapy) to reference treatment group (Herceptin IV + Chemotherapy).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.8651","paramType":"Hazard Ratio (HR)","paramValue":"0.98","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median time to event could not be determined because of a high number (\\>50%) of censored observations. Full range includes censored observations.","groupId":"OG000","lowerLimit":"1","upperLimit":"82","value":"NA"},{"comment":"The median time to event could not be determined because of a high number (\\>50%) of censored observations. Full range includes censored observations.","groupId":"OG001","lowerLimit":"1","upperLimit":"76","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"294"}],"units":"Participants"}],"description":"Protocol-defined events included disease recurrence or progression (local, regional, distant, contralateral) or death from any cause. Imaging was performed at specified visits for up to 5 years after last dose. Thereafter, participants were followed for survival only. EFS was estimated by Kaplan-Meier analysis and defined as the time from randomization to the first protocol-defined event.","dispersionType":"Full Range","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 Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could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":"MEDIAN","populationDescription":"ITT Population","reportingStatus":"POSTED","timeFrame":"Screening; Day 1 of Cycle 18 (cycle length of 21 days); and Months 6, 12, 24, 36, 48, 60 from last dose of Cycle 18; then every 6 months until withdrawal for any reason (up to approximately 87 months overall)","title":"Event-Free Survival (EFS)","type":"SECONDARY","unitOfMeasure":"months"}