{"analyses":[{"groupDescription":"Statistical Analysis for BICR Assessment","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.","statisticalMethod":"Cochran-Mantel-Haenszel"},{"groupDescription":"Statistical Analysis for Investigator Assessment","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Cochran-Mantel-Haenszel test adjusted for stratification factors: hormone receptor status, prior treatment with pertuzumab, and history of visceral disease, as defined by the IXRS.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"65.0","upperLimit":"74.1","value":"69.7"},{"groupId":"OG001","lowerLimit":"23.0","upperLimit":"36.0","value":"29.2"}]}],"title":"BICR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"69.6","upperLimit":"78.3","value":"74.1"},{"groupId":"OG001","lowerLimit":"20.8","upperLimit":"33.4","value":"26.7"}]}],"title":"Investigator Assessment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"406"},{"groupId":"OG001","value":"202"}],"units":"Participants"}],"description":"The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).","id":"OG000","title":"Trastuzumab Deruxtecan (T-DXd)"},{"description":"Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine or Lapatinib/Capecitabine.","id":"OG001","title":"Treatment of Investigator's/Physician's Choice (TPC)"}],"paramType":"NUMBER","populationDescription":"Objective response rate (ORR) was assessed in the Full Analysis Set at data cut-off date of 30 Jun 2022.","reportingStatus":"POSTED","timeFrame":"Baseline up to 46 months postdose","title":"Percentage of Participants With Objective Response Rate (ORR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}