{"groups":[{"description":"Capivasertib: 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off).\n\nFulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.","id":"FG000","title":"Capivasertib + Fulvestrant"},{"description":"Placebo: Placebo tablets matching capivasertib. 400 mg twice daily (2 tablets of 200 mg taken orally twice daily; total daily dose 800 mg) given on an intermittent weekly dosing schedule (4 days on/3 days off).\n\nFulvestrant: 500 mg (2 intramuscular injections of 250 mg/5 mL solution) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter.","id":"FG001","title":"Placebo + Fulvestrant"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"}],"type":"Subjective disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"209"},{"groupId":"FG001","numSubjects":"273"}],"type":"Condition under investigation worsened"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"44"},{"groupId":"FG001","numSubjects":"6"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}],"type":"Any reason not specifically recorded"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"355"},{"groupId":"FG001","numSubjects":"353"}],"type":"STARTED"},{"achievements":[{"comment":"Participants ongoing capivasertib/placebo at data cut-off","groupId":"FG000","numSubjects":"63"},{"comment":"Participants ongoing capivasertib/placebo at data cut-off","groupId":"FG001","numSubjects":"43"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"292"},{"groupId":"FG001","numSubjects":"310"}],"type":"NOT COMPLETED"}],"title":"Global Cohort"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}],"type":"Any reason not specifically recorded"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"2"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"47"}],"type":"Condition under investigation worsened"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}],"type":"Subjective disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"comment":"An additional 110 participants were enrolled into the China cohort only; 24 participants were in both the Global and China cohorts.","groupId":"FG000","numSubjects":"71"},{"comment":"An additional 110 participants were enrolled into the China cohort only; 24 participants were in both the Global and China cohorts.","groupId":"FG001","numSubjects":"63"}],"type":"STARTED"},{"achievements":[{"comment":"Participants ongoing capivasertib/placebo at data cut-off","groupId":"FG000","numSubjects":"18"},{"comment":"Participants ongoing capivasertib/placebo at data cut-off","groupId":"FG001","numSubjects":"10"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"53"}],"type":"NOT COMPLETED"}],"title":"China Cohort"}],"preAssignmentDetails":"A total of 818 participants were enrolled in the study. However, 24 participants were in both the Global and China cohorts.","recruitmentDetails":"A total of 708 participants in Global cohort (out of 818 participants in Global and China cohorts) were randomized to treatment. An additional 110 participants were enrolled into the China cohort only."}