{"description":"Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":9,"description":"Participants received glasdegib 100 milligrams (mg) tablet per oral (PO) once a day (QD) in combination with azacitidine 75 mg per meter squared (m\\^2)/day as subcutaneous (SC) injection or intravenous (IV) infusion for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":9,"seriousNumAffected":2,"seriousNumAtRisk":9,"title":"Glasdegib + Azacitidine"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants received placebo matched to Glasdegib in combination with azacitidine 75mg/m\\^2/day SC or IV for 7 days every 28 days. Treatment continued until objective disease progression or relapse, death, unacceptable toxicity, or participant refusal, whichever occurred first. Participants were followed up for 28 days after end of study treatment.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":5,"seriousNumAffected":1,"seriousNumAtRisk":5,"title":"Placebo + Azacitidine"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9},{"groupId":"EG001","numAffected":2,"numAtRisk":5}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Retinal detachment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Colitis ulcerative"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Inguinal hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Corynebacterium bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Epstein-Barr virus infection reactivation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"C-reactive protein increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Platelet count decreased"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Cardiopulmonary failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"COVID-19 pneumonia"}],"timeFrame":"From initiation of study treatment to study completed from 17-May-2021 to 02-Dec-2022 (approximately 565 days)"}