{"analyses":[{"ciLowerLimit":"0.44","ciPctValue":"95","ciUpperLimit":"0.66","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.54","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.96","upperLimit":"80.28","value":"77.12"},{"groupId":"OG001","lowerLimit":"86.07","upperLimit":"90.81","value":"88.44"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"743"},{"groupId":"OG001","value":"743"}],"units":"Participants"}],"description":"IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"OG000","title":"Trastuzumab"},{"description":"Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.","id":"OG001","title":"Trastuzumab Emtansine"}],"paramType":"NUMBER","populationDescription":"ITT population included all participants who were randomized to the study regardless of whether they received any study treatment.","reportingStatus":"POSTED","timeFrame":"At Year 3","title":"Invasive Disease-free Survival (IDFS) Rate at 3 Years","type":"PRIMARY","unitOfMeasure":"percentage of participants"}