{"analyses":[{"ciLowerLimit":"0.84","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.13","estimateComment":"HR for Herceptin 2-Year Arm versus Herceptin 1-Year Arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7251","paramType":"Hazard Ratio (HR)","paramValue":"0.97","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.2"},{"groupId":"OG001","value":"21.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1552"},{"groupId":"OG001","value":"1553"}],"units":"Participants"}],"description":"RDFS events included loco-regional or distant recurrence of breast cancer, development of contralateral breast cancer, or death from any cause. The percentage of participants with at least one RDFS 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 1Y2Y. In contrast to other study endpoints, RDFS compared to the Observation Arm was not a planned endpoint according to study protocol. Only RDFS in Herceptin 1-Year Arm versus Herceptin 2-Year Arm was a planned endpoint.","reportingStatus":"POSTED","timeFrame":"From Baseline until time of event (median of 8 years)","title":"Percentage of Participants With Restricted Disease-Free Survival (RDFS) Events in 1-Year Versus 2-Year Herceptin: 8-Year Median Follow-Up","type":"SECONDARY","unitOfMeasure":"percentage of participants"}