{"analyses":[{"ciLowerLimit":"1.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.71","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":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"1.95","statisticalComment":"Performed using a logistic regression model with factors for treatment and the stratification factors.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"1.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.87","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":"2.06","statisticalComment":"Performed using a logistic regression model with factors for treatment and the stratification factors.","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"6.96","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.05","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 response rate","paramValue":"13.55"},{"ciLowerLimit":"8.08","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"21.11","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 response rate","paramValue":"14.64"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.49","upperLimit":"41.61","value":"36.44"},{"groupId":"OG001","lowerLimit":"18.69","upperLimit":"27.53","value":"22.89"}]}],"title":"Confirmed response by BICR assessment based on IA1 data cut-off Raw Response Rate (%)"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"31.76","upperLimit":"41.89","value":"36.71"},{"groupId":"OG001","lowerLimit":"17.93","upperLimit":"26.67","value":"22.07"}]}],"title":"Confirmed response by investigator assessment based on FA data cut-off Raw Response Rate (%)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"}],"units":"Participants"}],"description":"Objective response rate is defined as the proportion of participants who have a confirmed CR or PR, as determined by the BICR/Investigator assessment, per RECIST 1.1.","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":"From date of randomization until event. Assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months for BICR assessment and assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months for investigator assessment.","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}