{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.043","statisticalComment":"Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral disease.","statisticalMethod":"Gray's test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.48","upperLimit":"30.91","value":"22.76"},{"groupId":"OG001","lowerLimit":"22.54","upperLimit":"36.14","value":"29.19"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"307"},{"groupId":"OG001","value":"314"}],"units":"Participants"}],"description":"Intervention for symptomatic metastatic central nervous system disease is defined as the time from randomization to the first start date of an intervention for symptomatic metastatic CNS disease. Subjects that do not have an intervention for symptomatic metastatic CNS and do not die will be censored at the last date known alive on or prior to the data cutoff. Deaths are treated as competing events. Percentage of participants with intervention for CNS, estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring.","dispersionType":"95% Confidence Interval","groups":[{"description":"neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m\\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.","id":"OG000","title":"Neratinib Plus Capecitabine"},{"description":"lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m\\^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.","id":"OG001","title":"Lapatinib Plus Capecitabine"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut.","title":"Intervention for Symptomatic Metastatic Central Nervous System Disease","type":"SECONDARY","unitOfMeasure":"percentage of participants"}