{"eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":25,"description":"All eligible patients will receive up to 2 cycles of CPX-351 for remission induction.","id":"EG000","otherNumAffected":23,"otherNumAtRisk":25,"seriousNumAffected":20,"seriousNumAtRisk":25,"title":"CPX-351 (Vyxeos)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25,"numEvents":5}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"General disorders and administration site conditions","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25,"numEvents":6}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Herpes simplex reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Papulopustular rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25,"numEvents":5}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":25,"numEvents":25}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Papilledema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"General disorders and administration site conditions","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":2}],"term":"Nervous system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"NCI CTCAE v5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Rash maculo-papular"}],"timeFrame":"Adverse events will be monitored from the time of first study intervention or treatment until 30 days after off-therapy. Participants will be monitored for survival up to 3 years from enrollment."}