{"analyses":[{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.07","estimateComment":"A hazard ratio less than 1 favours SoC + Durvalumab.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValueComment":"Descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"0.80","statisticalComment":"Model is unstratified.","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.76","estimateComment":"A hazard ratio less than 1 favours SoC + Durvalumab + Olaparib.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValueComment":"Descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"0.55","statisticalComment":"Model is unstratified.","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.21","estimateComment":"A hazard ratio less than 1 favours SoC + Durvalumab.","groupIds":["OG003","OG004"],"nonInferiorityType":"SUPERIORITY","pValueComment":"China cohort designed to provide descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"1.03","statisticalComment":"Model was stratified by disease status (recurrent versus newly diagnosed).","statisticalMethod":"Regression, Cox"},{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.90","estimateComment":"A hazard ratio less than 1 favours SoC + Durvalumab.","groupIds":["OG003","OG005"],"nonInferiorityType":"SUPERIORITY","pValueComment":"China cohort designed to provide descriptive analysis only.","paramType":"Hazard Ratio (HR)","paramValue":"1.38","statisticalComment":"Model was stratified by disease status (recurrent versus newly diagnosed).","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.4","upperLimit":"22.9","value":"19.1"},{"comment":"Insufficient PFS2 events to estimate upper confidence limit.","groupId":"OG001","lowerLimit":"18.7","upperLimit":"NA","value":"22.2"},{"comment":"Insufficient PFS2 events to estimate median and confidence limits.","groupId":"OG002","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Insufficient PFS2 events to estimate upper confidence limit.","groupId":"OG003","lowerLimit":"15.5","upperLimit":"NA","value":"24.2"},{"comment":"Insufficient PFS2 events to estimate upper confidence limit.","groupId":"OG004","lowerLimit":"15.3","upperLimit":"NA","value":"19.7"},{"comment":"Insufficient PFS2 events to estimate upper confidence limit.","groupId":"OG005","lowerLimit":"12.7","upperLimit":"NA","value":"15.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"238"},{"groupId":"OG002","value":"239"},{"groupId":"OG003","value":"44"},{"groupId":"OG004","value":"43"},{"groupId":"OG005","value":"42"}],"units":"Participants"}],"description":"To determine the efficacy 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 in newly diagnosed advanced or recurrent endometrial cancer patients by assessment of PFS2","dispersionType":"95% Confidence Interval","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"},{"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, patients without objective disease progression received durvalumab placebo (IV) Q4W and olaparib placebo (tablets) twice bd orally as maintenance treatment until disease progression.","id":"OG003","title":"China 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, patients without objective disease progression received 1500 mg durvalumab (IV) Q4W with olaparib placebo (tablets) bd orally as maintenance treatment until disease progression.","id":"OG004","title":"China 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":"OG005","title":"China Cohort - SoC + Durvalumab + Olaparib"}],"paramType":"MEDIAN","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). China FAS includes all patients who were randomised at sites in China and Hong Kong.","reportingStatus":"POSTED","timeFrame":"At baseline, every 9 to 18 wks, then every 12 wks until objective radiological disease progression. Assessments then per local practice every 12 wks until second progression. Assessed until 12Apr2023 DCO (08Jul2024 DCO for China cohort), up to 50 months","title":"Time From Randomisation to Second Progression or Death (PFS2) Based on Local Standard Clinical Practice","type":"SECONDARY","unitOfMeasure":"Months"}