{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.48","upperLimit":"1.41","value":"0.86"},{"groupId":"OG001","lowerLimit":"3.47","upperLimit":"5.49","value":"4.40"},{"groupId":"OG002","lowerLimit":"6.09","upperLimit":"8.64","value":"7.29"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1744"},{"groupId":"OG001","value":"1682"},{"groupId":"OG002","value":"1673"}],"units":"Participants"}],"description":"Secondary cardiac endpoint events included NYHA Class I or II CHF with a drop in LVEF measured by multiple-gated acquisition or electrocardiogram, unless the subsequent assessment of LVEF indicated a return to levels that did not meet the definition of a significant LVEF drop. A significant LVEF drop was defined as an absolute reduction of at least 10 percentage points from Baseline and to a value \\<50%. The percentage of participants with at least one secondary cardiac endpoint event was reported, excluding those with both a primary and secondary cardiac endpoint event. The 95% CI was calculated by the Pearson-Clopper method for a one-sample binomial.","dispersionType":"95% Confidence Interval","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":"Safety Population","reportingStatus":"POSTED","timeFrame":"From Baseline until time of event (maximum up to 10 years)","title":"Percentage of Participants With Secondary Cardiac Endpoint Events Compared to Observation: 10-Year Maximum Follow-Up","type":"SECONDARY","unitOfMeasure":"percentage of participants"}