{"analyses":[{"ciLowerLimit":"0.47","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.90","upperLimit":"77.65","value":"74.28"},{"groupId":"OG001","lowerLimit":"81.03","upperLimit":"86.62","value":"83.82"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"743"},{"groupId":"OG001","value":"743"}],"units":"Participants"}],"description":"DRFI was defined as the time between randomization and the date of distant breast cancer recurrence. 8-year DRFI event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 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 8","title":"DRFI Rate at 8 Years","type":"SECONDARY","unitOfMeasure":"percentage of participants"}