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(3.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":5}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":5}],"term":"Platelets (thrombocytopenia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac 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subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":5}],"term":"Hair loss/alopecia (scalp or body)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Pruritus/itching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Dysphagia (difficulty swallowing)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Bleeding gums"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Nose bleed"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":5}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Colitis, infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":5}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Abdomen infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Oral 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Infected ommaya"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Edema:limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":5}],"term":"Edema:head and neck"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":5}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":20},{"groupId":"EG001","numAffected":3,"numAtRisk":5}],"term":"Transaminase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":5}],"term":"ALT, SGPT (serum glutamic pyruvic transaminase) atinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":5}],"term":"AST, SGOT (serum glutamic oxaloacetic transaminase)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0}],"term":"Neuro symptoms - Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0}],"term":"Renal failuretumor lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Hematoma"}],"timeFrame":"Safety data was collected on Day 1 of each cycle of chemotherapy, for the previous cycle or monthly, whichever was less frequent and 30 days post last dose of study treatment. Treatment duration was at a median of 13 weeks (range 11-20) for high-risk patients and 10 weeks (range 9-12) for low-risk patients."}