{"analyses":[{"ciLowerLimit":"1.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.42","estimateComment":"An odds ratio \\> 1 favours Dato-DXd","groupDescription":"Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0006","paramType":"Odds Ratio (OR)","paramValue":"1.75","statisticalComment":"Performed using a logistic regression model with factors for treatment and the stratification factors.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.00","estimateComment":"An odds ratio \\> 1 favours Dato-DXd","groupDescription":"Dato-DXd versus ICC based on confirmed response by Investigator assessment based on FA data cut-off","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"2.12","statisticalComment":"Performed using a logistic regression model with factors for treatment and the stratification factors.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"4.93","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"18.16","estimateComment":"A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.","groupDescription":"Dato-DXd versus ICC based on confirmed response by BICR assessment based on IA1 data cut-off","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in raw disease control rate","paramValue":"11.58"},{"ciLowerLimit":"7.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.33","estimateComment":"A positive difference in response rates favours Dato-DXd. Calculated using the Miettinen-Nurminen method.","groupDescription":"Dato-DXd versus ICC based on confirmed response by Investigator assessment based on FA data cut-off","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in raw disease control rate","paramValue":"14.06"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"70.59","upperLimit":"79.68","value":"75.34"},{"groupId":"OG001","lowerLimit":"58.61","upperLimit":"68.69","value":"63.76"}]}],"title":"Response by BICR assessment based on IA1 data cut-off Raw disease control rate (%)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"76.40","upperLimit":"84.73","value":"80.82"},{"groupId":"OG001","lowerLimit":"61.68","upperLimit":"71.56","value":"66.76"}]}],"title":"Response by investigator assessment based on FA data cut-off Raw disease control rate (%)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"}],"units":"Participants"}],"description":"DCR is defined as the percentage of participants who have a confirmed CR or PR up to data cut-off date or who have SD for at least 11 weeks after randomization, per RECIST 1.1, as assessed BICR/per investigator assessment and derived from the raw tumor data.","groups":[{"description":"Arm 1: Dato-DXd","id":"OG000","title":"Dato-DXd"},{"description":"Arm 2: ICC (Capecitabine or Gemcitabine or Eribulin mesylate or Vinorelbine)","id":"OG001","title":"Investigator's Choice of Chemotherapy (ICC)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Assessed up to data cut-off (17Jul2023) to a maximum of 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of 33 months for investigator assessment.","title":"Disease Control Rate (DCR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}