{"analyses":[{"ciLowerLimit":"-2.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.6","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValueComment":"Descriptive analysis only.","paramType":"Least-squares Mean Difference","paramValue":"0.0","statisticalComment":"Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.","statisticalMethod":"Mixed model for repeated measures"},{"ciLowerLimit":"-3.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.6","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValueComment":"Descriptive analysis only.","paramType":"Least-squares Mean Difference","paramValue":"-0.9","statisticalComment":"Fixed effects for treatment, visit, and baseline score with the treatment by visit and baseline score by visit interaction. Random patient effect.","statisticalMethod":"Mixed model for repeated measures"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.93","value":"-2.8"},{"groupId":"OG001","spread":"0.92","value":"-2.7"},{"groupId":"OG002","spread":"0.88","value":"-3.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"187"},{"groupId":"OG001","value":"190"},{"groupId":"OG002","value":"199"}],"units":"Participants"}],"description":"To determine effects on symptoms, functioning, and overall HRQoL of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy alone in newly diagnosed advanced or recurrent endometrial cancer patients. The global health status/quality of life (QoL) is a score from 0 to 100. Higher scores on the global health status/QoL indicate better health status/function.","dispersionType":"Standard Error","groups":[{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with durvalumab placebo (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, participants without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.","id":"OG000","title":"Global Cohort - SoC"},{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, participants without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.","id":"OG001","title":"Global Cohort - SoC + Durvalumab"},{"description":"Platinum-based chemotherapy (paclitaxel and carboplatin) Q3W for a maximum of 6 cycles with 1120 mg durvalumab (IV) Q3W.\n\nFollowing completion of chemotherapy treatment, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with 300 mg olaparib (tablets) bd orally as maintenance treatment until disease progression.","id":"OG002","title":"Global Cohort - SoC + Durvalumab + Olaparib"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"FAS consisting of all patients randomised as part of global enrolment including patients from China who were randomised before the global recruitment was closed (up to and including 20 Apr 2022). All participants with a baseline and post baseline global health status/QoL available were analysed. This endpoint was not assessed in the China cohort as it was not prespecified in the SAP.","reportingStatus":"POSTED","timeFrame":"At baseline, every 3 wks until Wk 18, and every 4 wks until the second progression. Assessed until 12 Apr 2023 DCO, up to 35 months. The average treatment effect over the first 12 months after randomisation is presented.","title":"Change From Baseline in Global Health Status/QoL Score of the EORTC QLQ-C30","type":"SECONDARY","unitOfMeasure":"Score on a scale"}