{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0328","statisticalComment":"Stratified by hormone receptor status, number of prior HER2-directed regimens in the metastatic setting and visceral disease vs. non-visceral.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.3","upperLimit":"50.8","value":"44.5"},{"groupId":"OG001","lowerLimit":"29.8","upperLimit":"41.6","value":"35.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"256"},{"groupId":"OG001","value":"270"}],"units":"Participants"}],"description":"Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening.","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 either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.","title":"Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}