{"description":"An event may appear as both an AE \\& SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant \\& non-serious in another participant, or 1 participant may have experienced both a serious \\& non-serious event. Events were reported up to at least 28 days after last dose.","eventGroups":[{"description":"Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\\^2 (for a total cycle dose of 1.5 mg/m\\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).","id":"EG000","otherNumAffected":159,"otherNumAtRisk":164,"seriousNumAffected":85,"seriousNumAtRisk":164,"title":"Inotuzumab Ozogamicin"},{"description":"Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.","id":"EG001","otherNumAffected":143,"otherNumAtRisk":143,"seriousNumAffected":72,"seriousNumAtRisk":143,"title":"Defined Investigator's Choice of Chemotherapy"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":164},{"groupId":"EG001","numAffected":79,"numAtRisk":143}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":164},{"groupId":"EG001","numAffected":52,"numAtRisk":143}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":164},{"groupId":"EG001","numAffected":54,"numAtRisk":143}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":164},{"groupId":"EG001","numAffected":36,"numAtRisk":143}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":79,"numAtRisk":164},{"groupId":"EG001","numAffected":66,"numAtRisk":143}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":164},{"groupId":"EG001","numAffected":86,"numAtRisk":143}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":164},{"groupId":"EG001","numAffected":16,"numAtRisk":143}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":164},{"groupId":"EG001","numAffected":8,"numAtRisk":143}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":164},{"groupId":"EG001","numAffected":2,"numAtRisk":143}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":164},{"groupId":"EG001","numAffected":26,"numAtRisk":143}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":164},{"groupId":"EG001","numAffected":12,"numAtRisk":143}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":164},{"groupId":"EG001","numAffected":9,"numAtRisk":143}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":164},{"groupId":"EG001","numAffected":35,"numAtRisk":143}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":164},{"groupId":"EG001","numAffected":14,"numAtRisk":143}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":164},{"groupId":"EG001","numAffected":9,"numAtRisk":143}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General 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and procedural complications","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":164},{"groupId":"EG001","numAffected":4,"numAtRisk":143}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":164},{"groupId":"EG001","numAffected":18,"numAtRisk":143}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":164},{"groupId":"EG001","numAffected":16,"numAtRisk":143}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":164},{"groupId":"EG001","numAffected":10,"numAtRisk":143}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":164},{"groupId":"EG001","numAffected":12,"numAtRisk":143}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":164},{"groupId":"EG001","numAffected":1,"numAtRisk":143}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":164},{"groupId":"EG001","numAffected":9,"numAtRisk":143}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 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