{"description":"Patients who received treatment and were assessed for adverse events are included in the analysis of serious adverse events as well as other adverse events.","eventGroups":[{"deathsNumAffected":103,"deathsNumAtRisk":479,"description":"Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age \\< 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age \\< 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) \\>= 0.75 x 10\\^9/L and platelets \\> 75 x 10\\^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age \\< 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in cycle 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.","id":"EG000","otherNumAffected":227,"otherNumAtRisk":479,"seriousNumAffected":457,"seriousNumAtRisk":479,"title":"Induction"},{"deathsNumAffected":28,"deathsNumAtRisk":316,"description":"Beginning 4 weeks after the completion of cycle 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.","id":"EG001","otherNumAffected":153,"otherNumAtRisk":316,"seriousNumAffected":166,"seriousNumAtRisk":316,"title":"Intensification"},{"deathsNumAffected":23,"deathsNumAtRisk":146,"description":"Patients receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion.\n\nConsolidation therapy: Beginning after the second cycle of blinatumomab, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, 22; vincristine sulfate IV on days 1, 8, 15, 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \\< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1. Patients repeat cycle 4 and then receive blinatumomab IV continuously on days 1-28.","id":"EG002","otherNumAffected":94,"otherNumAtRisk":146,"seriousNumAffected":134,"seriousNumAtRisk":146,"title":"Blinatumomab"},{"deathsNumAffected":31,"deathsNumAtRisk":126,"description":"Patients undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion.\n\nConsolidation therapy: After intensification therapy, patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age \\< 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1.","id":"EG003","otherNumAffected":65,"otherNumAtRisk":126,"seriousNumAffected":121,"seriousNumAtRisk":126,"title":"No Blinatumomab"},{"deathsNumAffected":27,"deathsNumAtRisk":148,"description":"Within 6 weeks after beginning last cycle of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 2 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.","id":"EG004","otherNumAffected":93,"otherNumAtRisk":148,"seriousNumAffected":121,"seriousNumAtRisk":148,"title":"Maintenance"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":479},{"groupId":"EG001","numAffected":83,"numAtRisk":316},{"groupId":"EG002","numAffected":67,"numAtRisk":146},{"groupId":"EG003","numAffected":38,"numAtRisk":126},{"groupId":"EG004","numAffected":60,"numAtRisk":148}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":16,"numAtRisk":146},{"groupId":"EG003","numAffected":7,"numAtRisk":126},{"groupId":"EG004","numAffected":18,"numAtRisk":148}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":14,"numAtRisk":146},{"groupId":"EG003","numAffected":2,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":479},{"groupId":"EG001","numAffected":18,"numAtRisk":316},{"groupId":"EG002","numAffected":7,"numAtRisk":146},{"groupId":"EG003","numAffected":11,"numAtRisk":126},{"groupId":"EG004","numAffected":15,"numAtRisk":148}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":479},{"groupId":"EG001","numAffected":24,"numAtRisk":316},{"groupId":"EG002","numAffected":28,"numAtRisk":146},{"groupId":"EG003","numAffected":19,"numAtRisk":126},{"groupId":"EG004","numAffected":20,"numAtRisk":148}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":479},{"groupId":"EG001","numAffected":19,"numAtRisk":316},{"groupId":"EG002","numAffected":16,"numAtRisk":146},{"groupId":"EG003","numAffected":6,"numAtRisk":126},{"groupId":"EG004","numAffected":13,"numAtRisk":148}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":479},{"groupId":"EG001","numAffected":32,"numAtRisk":316},{"groupId":"EG002","numAffected":32,"numAtRisk":146},{"groupId":"EG003","numAffected":22,"numAtRisk":126},{"groupId":"EG004","numAffected":13,"numAtRisk":148}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":16,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":8,"numAtRisk":146},{"groupId":"EG003","numAffected":3,"numAtRisk":126},{"groupId":"EG004","numAffected":19,"numAtRisk":148}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":479},{"groupId":"EG001","numAffected":16,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":16,"numAtRisk":148}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":10,"numAtRisk":148}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":14,"numAtRisk":148}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":42,"numAtRisk":316},{"groupId":"EG002","numAffected":33,"numAtRisk":146},{"groupId":"EG003","numAffected":4,"numAtRisk":126},{"groupId":"EG004","numAffected":40,"numAtRisk":148}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":479},{"groupId":"EG001","numAffected":70,"numAtRisk":316},{"groupId":"EG002","numAffected":56,"numAtRisk":146},{"groupId":"EG003","numAffected":27,"numAtRisk":126},{"groupId":"EG004","numAffected":55,"numAtRisk":148}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":14,"numAtRisk":148}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":479},{"groupId":"EG001","numAffected":27,"numAtRisk":316},{"groupId":"EG002","numAffected":44,"numAtRisk":146},{"groupId":"EG003","numAffected":26,"numAtRisk":126},{"groupId":"EG004","numAffected":23,"numAtRisk":148}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":9,"numAtRisk":146},{"groupId":"EG003","numAffected":3,"numAtRisk":126},{"groupId":"EG004","numAffected":17,"numAtRisk":148}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":19,"numAtRisk":146},{"groupId":"EG003","numAffected":2,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":8,"numAtRisk":146},{"groupId":"EG003","numAffected":1,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":244,"numAtRisk":479},{"groupId":"EG001","numAffected":56,"numAtRisk":316},{"groupId":"EG002","numAffected":38,"numAtRisk":146},{"groupId":"EG003","numAffected":50,"numAtRisk":126},{"groupId":"EG004","numAffected":17,"numAtRisk":148}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":124,"numAtRisk":479},{"groupId":"EG001","numAffected":1,"numAtRisk":316},{"groupId":"EG002","numAffected":31,"numAtRisk":146},{"groupId":"EG003","numAffected":34,"numAtRisk":126},{"groupId":"EG004","numAffected":10,"numAtRisk":148}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":1,"numAtRisk":148}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":2,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":1,"numAtRisk":148}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Chest pain - cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":1,"numAtRisk":148}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Pericarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":2,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":1,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":479},{"groupId":"EG001","numAffected":4,"numAtRisk":316},{"groupId":"EG002","numAffected":5,"numAtRisk":146},{"groupId":"EG003","numAffected":5,"numAtRisk":126},{"groupId":"EG004","numAffected":3,"numAtRisk":148}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":2,"numAtRisk":146},{"groupId":"EG003","numAffected":1,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":1,"numAtRisk":146},{"groupId":"EG003","numAffected":0,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":479},{"groupId":"EG001","numAffected":0,"numAtRisk":316},{"groupId":"EG002","numAffected":0,"numAtRisk":146},{"groupId":"EG003","numAffected":1,"numAtRisk":126},{"groupId":"EG004","numAffected":0,"numAtRisk":148}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 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