{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.87","estimateComment":"HR for Herceptin 1-Year Arm versus Observation Arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.76"},{"groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.85","estimateComment":"HR for Herceptin 2-Year Arm versus Observation Arm.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.75"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28.8"},{"groupId":"OG001","value":"23.4"},{"groupId":"OG002","value":"23.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1697"},{"groupId":"OG001","value":"1702"},{"groupId":"OG002","value":"1700"}],"units":"Participants"}],"description":"DDFS events included distant tumor recurrence, second primary cancer, or contralateral breast cancer. The percentage of participants with at least one DDFS event was reported.","groups":[{"description":"Participants who completed definitive surgery and systemic adjuvant chemotherapy were observed for efficacy and safety until 10 years from individual randomization and for survival until 10 years after enrollment of the last participant. No Herceptin was provided.","id":"OG000","title":"Observation 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 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":"OG001","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":"OG002","title":"Herceptin 2-Year Arm"}],"paramType":"NUMBER","populationDescription":"FAS Population","reportingStatus":"POSTED","timeFrame":"From Baseline until time of event (median of 8 years)","title":"Percentage of Participants With Distant Disease-Free Survival (DDFS) Events Compared to Observation: 8-Year Median Follow-Up","type":"SECONDARY","unitOfMeasure":"percentage of participants"}