{"analyses":[{"ciLowerLimit":"0.47","ciPctValue":"95","ciUpperLimit":"0.76","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80.43","upperLimit":"86.08","value":"83.26"},{"groupId":"OG001","lowerLimit":"87.72","upperLimit":"92.19","value":"89.95"}]}]}],"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. 3-year DRFI event-free rate in the ITT population was estimated using 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":"Distant Recurrence-free Interval (DRFI) Rate at 3 Years","type":"SECONDARY","unitOfMeasure":"percentage of participants"}