{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.28","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.79","estimateComment":"HR for Herceptin 2-Year Arm versus Observation Arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.47"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.2"},{"groupId":"OG001","value":"1.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1693"},{"groupId":"OG001","value":"1694"}],"units":"Participants"}],"description":"OS events referred to death from any cause. The percentage of participants who died was reported. The analysis of the Herceptin 2-Year Arm against the Observation Arm after 1-year median follow-up, as reported below, was performed for an IDMC in 2005 at a time the Sponsor was blinded. The analysis of the Herceptin 1-Year Arm against the Observation Arm was performed by the Sponsor in 2006 following database cleaning. Therefore, these data are reported under a separate Outcome Measure.","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 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. The \"Number of Participants Analyzed\" reflects the number with data for the endpoint.","reportingStatus":"POSTED","timeFrame":"From Baseline until time of event (median of 1 year)","title":"Percentage of Participants With OS Events in Herceptin 2-Year Arm Compared to Observation: 1-Year Median Follow-Up","type":"SECONDARY","unitOfMeasure":"percentage of participants"}