{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.04","estimateComment":"Stratified Cox Proportional Hazards model. A hazard ratio \\< 1 favours Dato-DXd.","groupDescription":"Dato-DXd versus ICC","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.1155","paramType":"Hazard Ratio (HR)","paramValue":"0.83","statisticalComment":"Adjusted for stratification factors","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"5.0","value":"3.4"},{"groupId":"OG001","lowerLimit":"1.5","upperLimit":"2.9","value":"2.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"365"},{"groupId":"OG001","value":"367"}],"units":"Participants"}],"description":"Time to deterioration in global health status/QoL as measured by the global health status/QoL scale from EORTC QLQ-C30. Deterioration is defined as a 16.6 decrease in score relative to baseline score.","dispersionType":"95% Confidence Interval","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":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From date of randomization to 18 weeks post-progression. Assessments occur every 3 weeks then every 6 weeks until 18 weeks post-progression and at end of treatment visit. Assessed up to data cut-off (24Jul2024) to a maximum of approximately 33 months.","title":"Clinical Outcome Assessment- TTD in GHS","type":"SECONDARY","unitOfMeasure":"Months"}