{"description":"All-Cause Mortality, Progression-free Survival, and Overall Survival were assessed with the Intention-to-Treat Population, which consisted of all randomized participants. Adverse Events (Serious and Other) reporting reflects the Safety Population, which consisted of all participants who received at least 1 dose of study medication. All deaths regardless of causality are reported in the All-Cause Mortality section. Only deaths leading to study discontinuation are reported in the Participant Flow.","eventGroups":[{"deathsNumAffected":70,"deathsNumAtRisk":239,"description":"Participants in Arm 1 will receive elacestrant\n\nElacestrant: 400 mg/day once daily oral dosing","id":"EG000","otherNumAffected":215,"otherNumAtRisk":237,"seriousNumAffected":29,"seriousNumAtRisk":237,"title":"Elacestrant"},{"deathsNumAffected":80,"deathsNumAtRisk":239,"description":"Participants in Arm 2 will receive Investigator's choice of one of the Standard-of-Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)\n\nStandard of Care:\n\n* Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle\n* Anastrozole 1 mg/day on a continuous dosing schedule\n* Letrozole: 2.5 mg/day on a continuous dosing schedule\n* Exemestane: 25 mg/day on a continuous dosing schedule","id":"EG001","otherNumAffected":195,"otherNumAtRisk":230,"seriousNumAffected":25,"seriousNumAtRisk":230,"title":"Standard of Care (SoC)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":237},{"groupId":"EG001","numAffected":17,"numAtRisk":230}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":83,"numAtRisk":237},{"groupId":"EG001","numAffected":44,"numAtRisk":230}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":237},{"groupId":"EG001","numAffected":13,"numAtRisk":230}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":237},{"groupId":"EG001","numAffected":44,"numAtRisk":230}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":237},{"groupId":"EG001","numAffected":19,"numAtRisk":230}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":14,"numAtRisk":230}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":237},{"groupId":"EG001","numAffected":12,"numAtRisk":230}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":237},{"groupId":"EG001","numAffected":29,"numAtRisk":230}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":237},{"groupId":"EG001","numAffected":24,"numAtRisk":230}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":237},{"groupId":"EG001","numAffected":17,"numAtRisk":230}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":237},{"groupId":"EG001","numAffected":22,"numAtRisk":230}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":237},{"groupId":"EG001","numAffected":37,"numAtRisk":230}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":237},{"groupId":"EG001","numAffected":22,"numAtRisk":230}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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23.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":237},{"groupId":"EG001","numAffected":0,"numAtRisk":230}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":237},{"groupId":"EG001","numAffected":0,"numAtRisk":230}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":237},{"groupId":"EG001","numAffected":0,"numAtRisk":230}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":2,"numAtRisk":230}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal 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infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":1,"numAtRisk":230}],"term":"Device related sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":1,"numAtRisk":230}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":2,"numAtRisk":230}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":237},{"groupId":"EG001","numAffected":0,"numAtRisk":230}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":1,"numAtRisk":230}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":237},{"groupId":"EG001","numAffected":1,"numAtRisk":230}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":237},{"groupId":"EG001","numAffected":0,"numAtRisk":230}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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