{"description":"All-cause mortality:The Efficacy Analysis Set included all participants randomly assigned to study treatment.\n\nSerious and other adverse events:The Safety Analysis Set included all participants randomly assigned to study treatment who received any amount of study treatment or any component of a multi-dose study treatment regimen.\n\nAs pre-specified in the protocol, participants were grouped, and data was collected according to treatment received (Guadecitabine/Treatment Choice)for adverse events.","eventGroups":[{"deathsNumAffected":237,"deathsNumAtRisk":277,"description":"Participants received Guadecitabine 60 mg/m\\^2, SC, on Days 1-5 of each 28-day cycle for at least 6 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Participants received Guadecitabine treatment beyond 6 cycles as long as the participant continued to benefit based on investigator judgment and participant response and tolerability (or up to a maximum of 36 cycles).","id":"EG000","otherNumAffected":266,"otherNumAtRisk":270,"seriousNumAffected":216,"seriousNumAtRisk":270,"title":"Guadecitabine"},{"deathsNumAffected":122,"deathsNumAtRisk":140,"description":"Participants received one of the three treatment choice options:\n\n1. LDAC 20 mg/m\\^2 SC/IV once daily for 14 days of each 28-day cycles for at least 4 cycles in absence of disease progression or unacceptable toxicity.Participants who were responding or had stable disease were to continue treatment as per standard institutional practice.\n2. Standard IC of a 7+3 regimen:Cytarabine 100-200 mg/m\\^2/day given as continuous infusion for 7 days and anthracycline(daunorubicin(45-60 mg)/idarubicin(9-12 mg)/mitoxantrone(8-12 mg)/m\\^2) by IV infusion for 3 days of each 28-day cycles.\n3. BSC as needed during the treatment included,but was not limited to,blood transfusions(RBCs or platelets),growth factors including erythropoiesis stimulating agents,granulocyte stimulating factors,iron chelating therapy,and broad-spectrum antibiotics and/or antifungals.\n\nDuration for treatment choice was as per locally approved prescribing information and institutional standard practice or up to a maximum 30 cycles.","id":"EG001","otherNumAffected":107,"otherNumAtRisk":122,"seriousNumAffected":65,"seriousNumAtRisk":122,"title":"Treatment Choice"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":270},{"groupId":"EG001","numAffected":22,"numAtRisk":122}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":270},{"groupId":"EG001","numAffected":6,"numAtRisk":122}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":270},{"groupId":"EG001","numAffected":12,"numAtRisk":122}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":270},{"groupId":"EG001","numAffected":19,"numAtRisk":122}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":270},{"groupId":"EG001","numAffected":25,"numAtRisk":122}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":270},{"groupId":"EG001","numAffected":6,"numAtRisk":122}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":270},{"groupId":"EG001","numAffected":12,"numAtRisk":122}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":270},{"groupId":"EG001","numAffected":20,"numAtRisk":122}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":270},{"groupId":"EG001","numAffected":4,"numAtRisk":122}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":270},{"groupId":"EG001","numAffected":15,"numAtRisk":122}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":270},{"groupId":"EG001","numAffected":9,"numAtRisk":122}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":270},{"groupId":"EG001","numAffected":14,"numAtRisk":122}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":270},{"groupId":"EG001","numAffected":24,"numAtRisk":122}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":270},{"groupId":"EG001","numAffected":4,"numAtRisk":122}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":270},{"groupId":"EG001","numAffected":3,"numAtRisk":122}],"term":"Transfusion Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Alanine Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Aspartate Aminotransferase Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Blood Creatinine Increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":270},{"groupId":"EG001","numAffected":6,"numAtRisk":122}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":270},{"groupId":"EG001","numAffected":6,"numAtRisk":122}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":270},{"groupId":"EG001","numAffected":3,"numAtRisk":122}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":270},{"groupId":"EG001","numAffected":2,"numAtRisk":122}],"term":"Musculoskeletal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":270},{"groupId":"EG001","numAffected":9,"numAtRisk":122}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":270},{"groupId":"EG001","numAffected":8,"numAtRisk":122}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":270},{"groupId":"EG001","numAffected":11,"numAtRisk":122}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":270},{"groupId":"EG001","numAffected":21,"numAtRisk":122}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":270},{"groupId":"EG001","numAffected":3,"numAtRisk":122}],"term":"Oropharyngeal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":270},{"groupId":"EG001","numAffected":2,"numAtRisk":122}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":270},{"groupId":"EG001","numAffected":2,"numAtRisk":122}],"term":"Petechiae"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":270},{"groupId":"EG001","numAffected":2,"numAtRisk":122}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":270},{"groupId":"EG001","numAffected":7,"numAtRisk":122}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":270},{"groupId":"EG001","numAffected":5,"numAtRisk":122}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":270},{"groupId":"EG001","numAffected":3,"numAtRisk":122}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":270},{"groupId":"EG001","numAffected":19,"numAtRisk":122}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic 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21.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":270},{"groupId":"EG001","numAffected":1,"numAtRisk":122}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":270},{"groupId":"EG001","numAffected":0,"numAtRisk":122}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":270},{"groupId":"EG001","numAffected":0,"numAtRisk":122}],"term":"Leukostasis Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":270},{"groupId":"EG001","numAffected":0,"numAtRisk":122}],"term":"Thrombocytopenic Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":270},{"groupId":"EG001","numAffected":1,"numAtRisk":122}],"term":"Agranulocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":270},{"groupId":"EG001","numAffected":1,"numAtRisk":122}],"term":"Bone Marrow Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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