{"analyses":[{"ciLowerLimit":"0.89","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.17","estimateComment":"HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7962","paramType":"Hazard Ratio (HR)","paramValue":"1.02","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.8"},{"groupId":"OG001","value":"26.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1552"},{"groupId":"OG001","value":"1553"}],"units":"Participants"}],"description":"DFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer or second non-breast malignancy other than basal or squamous carcinoma of the skin and carcinoma in situ of the cervix, or death from any cause. The percentage of participants with at least one DFS event was reported.","groups":[{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 1 year or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.","id":"OG000","title":"Herceptin 1-Year Arm"},{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy received a loading dose of Herceptin as 8 mg/kg via IV infusion on Day 1, followed by a maintenance dose of 6 mg/kg via IV infusion 3 weeks later and thereafter every 3 weeks for 2 years or until disease recurrence, whichever occurred first. Participants were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant.","id":"OG001","title":"Herceptin 2-Year Arm"}],"paramType":"NUMBER","populationDescription":"FAS Population 1-Year Herceptin Versus 2-Year Herceptin (1Y2Y): Participants without a DFS event and still under follow-up at the pre-defined landmark of 366 days after randomization, analyzed when intent-to-treat principle was applied for comparison of 1 year versus 2 years of Herceptin.","reportingStatus":"POSTED","timeFrame":"From Baseline until time of event (maximum of 10 years)","title":"Percentage of Participants With DFS Events in 1-Year Versus 2-Year Herceptin: 10-Year Maximum Follow-Up","type":"SECONDARY","unitOfMeasure":"percentage of participants"}