{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1201","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":"27.1","upperLimit":"38.9","value":"32.8"},{"groupId":"OG001","lowerLimit":"21.5","upperLimit":"32.4","value":"26.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"256"},{"groupId":"OG001","value":"270"}],"units":"Participants"}],"description":"Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.","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 confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.","title":"Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}