{"analyses":[{"ciLowerLimit":"0.46","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.69","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.57","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"73.82","upperLimit":"80.15","value":"76.98"},{"groupId":"OG001","lowerLimit":"85.45","upperLimit":"90.29","value":"87.87"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"743"},{"groupId":"OG001","value":"743"}],"units":"Participants"}],"description":"IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ \\[CIS\\] of any site). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC 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":"IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years","type":"SECONDARY","unitOfMeasure":"percentage of participants"}