{"description":"Systemic assessment was used for collection of adverse events including:\n\n* Real time reporting of significant events by treating team\n* Regular communication with families and close monitoring of medical records, laboratory results, and imaging by dedicated research nurse (daily for inpatient setting and weekly for outpatient setting)\n* Biweekly review of AEs by PI and treating team for accuracy and completion","eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":206,"description":"Patients randomized on the first day of continuation phase to receive 3500 units/m\\^2 dose of PEG-asparaginase","id":"EG000","otherNumAffected":206,"otherNumAtRisk":206,"seriousNumAffected":0,"seriousNumAtRisk":206,"title":"PEG 3500 Units/m^2"},{"deathsNumAffected":15,"deathsNumAtRisk":208,"description":"Patients randomized on the first day of continuation phase to receive 2,500 units/m\\^2 dose of 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defined as ANC <1.0 x 10e9/L)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":206,"numEvents":22},{"groupId":"EG001","numAffected":10,"numAtRisk":208,"numEvents":11},{"groupId":"EG002","numAffected":13,"numAtRisk":184,"numEvents":14}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":206,"numEvents":19},{"groupId":"EG001","numAffected":12,"numAtRisk":208,"numEvents":13},{"groupId":"EG002","numAffected":11,"numAtRisk":184,"numEvents":12}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":206,"numEvents":64},{"groupId":"EG001","numAffected":63,"numAtRisk":208,"numEvents":78},{"groupId":"EG002","numAffected":36,"numAtRisk":184,"numEvents":46}],"term":"Mucositis/stomatitis (functional/symptomatic), Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":206,"numEvents":25},{"groupId":"EG001","numAffected":25,"numAtRisk":208,"numEvents":37},{"groupId":"EG002","numAffected":19,"numAtRisk":184,"numEvents":21}],"term":"Typhlitis (cecal inflammation)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 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3.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":206,"numEvents":49},{"groupId":"EG001","numAffected":48,"numAtRisk":208,"numEvents":66},{"groupId":"EG002","numAffected":45,"numAtRisk":184,"numEvents":51}],"term":"Infection, Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":206,"numEvents":16},{"groupId":"EG001","numAffected":17,"numAtRisk":208,"numEvents":22},{"groupId":"EG002","numAffected":8,"numAtRisk":184,"numEvents":8}],"term":"Infection, Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":206,"numEvents":13},{"groupId":"EG001","numAffected":17,"numAtRisk":208,"numEvents":23},{"groupId":"EG002","numAffected":8,"numAtRisk":184,"numEvents":10}],"term":"Infection, Lip/perioral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":206,"numEvents":42},{"groupId":"EG001","numAffected":47,"numAtRisk":208,"numEvents":63},{"groupId":"EG002","numAffected":22,"numAtRisk":184,"numEvents":28}],"term":"Infection, Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":206,"numEvents":36},{"groupId":"EG001","numAffected":38,"numAtRisk":208,"numEvents":48},{"groupId":"EG002","numAffected":22,"numAtRisk":184,"numEvents":28}],"term":"Infection, Middle ear (otitis media)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":206,"numEvents":41},{"groupId":"EG001","numAffected":35,"numAtRisk":208,"numEvents":55},{"groupId":"EG002","numAffected":27,"numAtRisk":184,"numEvents":36}],"term":"Infection, Oral cavity-gums (gingivitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":206,"numEvents":7},{"groupId":"EG001","numAffected":15,"numAtRisk":208,"numEvents":15},{"groupId":"EG002","numAffected":11,"numAtRisk":184,"numEvents":11}],"term":"Infection, Rectum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":206,"numEvents":25},{"groupId":"EG001","numAffected":23,"numAtRisk":208,"numEvents":25},{"groupId":"EG002","numAffected":6,"numAtRisk":184,"numEvents":8}],"term":"Infection, Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":206,"numEvents":52},{"groupId":"EG001","numAffected":41,"numAtRisk":208,"numEvents":47},{"groupId":"EG002","numAffected":39,"numAtRisk":184,"numEvents":49}],"term":"Infection, Skin (cellulitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":92,"numAtRisk":206,"numEvents":129},{"groupId":"EG001","numAffected":110,"numAtRisk":208,"numEvents":186},{"groupId":"EG002","numAffected":85,"numAtRisk":184,"numEvents":143}],"term":"Infection, Upper airway NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":206,"numEvents":15},{"groupId":"EG001","numAffected":14,"numAtRisk":208,"numEvents":22},{"groupId":"EG002","numAffected":7,"numAtRisk":184,"numEvents":8}],"term":"Infection, Urinary tract NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":206,"numEvents":33},{"groupId":"EG001","numAffected":26,"numAtRisk":208,"numEvents":27},{"groupId":"EG002","numAffected":20,"numAtRisk":184,"numEvents":25}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Blood"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":206,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":208,"numEvents":8},{"groupId":"EG002","numAffected":8,"numAtRisk":184,"numEvents":8}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":206,"numEvents":22},{"groupId":"EG001","numAffected":18,"numAtRisk":208,"numEvents":23},{"groupId":"EG002","numAffected":15,"numAtRisk":184,"numEvents":16}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Conjunctiva"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":206,"numEvents":13},{"groupId":"EG001","numAffected":13,"numAtRisk":208,"numEvents":15},{"groupId":"EG002","numAffected":7,"numAtRisk":184,"numEvents":8}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, External ear (otitis externa)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":206,"numEvents":74},{"groupId":"EG001","numAffected":28,"numAtRisk":208,"numEvents":56},{"groupId":"EG002","numAffected":14,"numAtRisk":184,"numEvents":32}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Lip/perioral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":49,"numAtRisk":206,"numEvents":57},{"groupId":"EG001","numAffected":46,"numAtRisk":208,"numEvents":50},{"groupId":"EG002","numAffected":30,"numAtRisk":184,"numEvents":38}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Lung (pneumonia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":206,"numEvents":197},{"groupId":"EG001","numAffected":80,"numAtRisk":208,"numEvents":146},{"groupId":"EG002","numAffected":56,"numAtRisk":184,"numEvents":117}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Middle ear (otitis media)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":206,"numEvents":82},{"groupId":"EG001","numAffected":48,"numAtRisk":208,"numEvents":92},{"groupId":"EG002","numAffected":47,"numAtRisk":184,"numEvents":96}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Oral cavity-gums (gingivitis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":206,"numEvents":136},{"groupId":"EG001","numAffected":51,"numAtRisk":208,"numEvents":78},{"groupId":"EG002","numAffected":29,"numAtRisk":184,"numEvents":46}],"term":"Infection with normal ANC or Grade 1 or 2 neutrophils, Sinus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 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(non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":206,"numEvents":25},{"groupId":"EG001","numAffected":36,"numAtRisk":208,"numEvents":36},{"groupId":"EG002","numAffected":24,"numAtRisk":184,"numEvents":24}],"term":"Tumor lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":206,"numEvents":9},{"groupId":"EG001","numAffected":12,"numAtRisk":208,"numEvents":12},{"groupId":"EG002","numAffected":12,"numAtRisk":184,"numEvents":12}],"term":"Thrombosis/embolism (vascular access-related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE Version 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Extremity-limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":206,"numEvents":27},{"groupId":"EG001","numAffected":20,"numAtRisk":208,"numEvents":24},{"groupId":"EG002","numAffected":18,"numAtRisk":184,"numEvents":19}],"term":"Pain, Head/headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":155,"numAtRisk":206,"numEvents":221},{"groupId":"EG001","numAffected":160,"numAtRisk":208,"numEvents":218},{"groupId":"EG002","numAffected":128,"numAtRisk":184,"numEvents":157}],"term":"Pain, Neuralgia/peripheral nerve"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":208,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":184,"numEvents":1}],"term":"Thrombosis/thrombus/embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Documented clinically or microbiologically with Grade 3 or 4 neutrophils (ANC \\<1.0 x 10e9/L)","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE Version 3.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":206,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":208,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":184,"numEvents":1}],"term":"Infection, Blood"}],"timeFrame":"Through 1 month after therapy completion, approximately 25 months"}