{"analyses":[{"ciLowerLimit":"0.4012","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.6444","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Two-sided p-value from stratified log-rank test, Hazard ratio and 95% CI from stratified Cox proportional hazards model using stratification factors: HER2 status, number of prior lines of chemotherapy, hormone Receptor/CDK status, as defined by IXRS.","paramType":"Cox Proportional Hazard","paramValue":"0.5085","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.5","upperLimit":"11.5","value":"10.1"},{"groupId":"OG001","lowerLimit":"4.4","upperLimit":"7.1","value":"5.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"331"},{"groupId":"OG001","value":"163"}],"units":"Participants"}],"description":"Progression-free survival (PFS), defined as at least a 20% increase in the sum of diameters of target lesions, was assessed from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever came first. PFS was based on blinded independent central review (BICR) in the hormone receptor-positive cohort according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1. Median PFS was from Kaplan-Meier analysis. Confidence interval for median was computed using the Brookmeyer-Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy were randomized to receive an intravenous infusion of DS8201a (initial dose of 5.4 mg/kg) over approximately 90 minutes. If there was no infusion-related reaction (IRR), T-DXd doses after the initial dose of 5.4 mg/kg were infused over a minimum of 30 minutes.","id":"OG000","title":"Trastuzumab Deruxtecan (T-DXd)"},{"description":"Participants with HER2-low, unresectable, and/or metastatic breast cancer who were previously treated with chemotherapy and randomized to a physician's choice (capecitabine, eribulin, gemcitabine, paclitaxel, and nab-paclitaxel) in which the dose, regimen, administration, and dose modification followed the label approved in the country of drug administration or the National Comprehensive Cancer Network guidelines.","id":"OG001","title":"Physician's Choice"}],"paramType":"MEDIAN","populationDescription":"Progression-free survival (PFS) was assessed in the Hormone Receptor-Positive cohort of Full Analysis Set.","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the earliest date of the first objective documentation of radiographic disease progression or death due to any cause, up to approximately 3 years","title":"Progression-free Survival (PFS) Based on Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive Cohort in Participants With HER2-low Breast Cancer","type":"PRIMARY","unitOfMeasure":"months"}