{"analyses":[{"ciLowerLimit":"0.62","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.81","estimateComment":"The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.","groupIds":["OG000","OG001"],"nonInferiorityComment":"The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.","nonInferiorityType":"NON_INFERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"1.06"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"30.5","upperLimit":"53.1","value":"42.0"},{"groupId":"OG001","lowerLimit":"39.0","upperLimit":"59.0","value":"49.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"148"},{"groupId":"OG001","value":"160"}],"units":"Participants"}],"description":"IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nCisplatin: Given IV","id":"OG000","title":"Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)"},{"description":"Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCapecitabine: Given PO","id":"OG001","title":"Arm C (Capecitabine) (Open to Accrual 6/22/2016)"}],"paramType":"NUMBER","populationDescription":"The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).","reportingStatus":"POSTED","timeFrame":"No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.","title":"3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients","type":"PRIMARY","unitOfMeasure":"percentage of participants"}