{"description":"There are n=42 pts enrolled to group Clofarabine 52 mg/m² to Assess Efficacy in AML Patients, 2 pts ineligible \\& 1 inevaluable for response. For toxicity, ineligible pts are excluded, but the inevaluable pt is included for analysis of toxicity resulting in n=40. OM #2 reports the number of pts having at least 1, gr 3 or higher AE during therapy. Pts with SAEs are not determined by this definition, but by whether a pt had at least 1 reportable AE requiring an AdEERs report during therapy.","eventGroups":[{"description":"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG000","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":5,"seriousNumAtRisk":8,"title":"Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients."},{"description":"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG001","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Clofarabine 40 mg/m² to Assess Feasibility in AML Patients."},{"description":"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients."},{"description":"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG003","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":7,"seriousNumAtRisk":10,"title":"Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients."},{"description":"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG004","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"Clofarabine 52 mg/m² to Assess Feasibility in AML Patients."},{"description":"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG005","otherNumAffected":38,"otherNumAtRisk":40,"seriousNumAffected":14,"seriousNumAtRisk":40,"title":"Clofarabine 52 mg/m² to Assess Efficacy in AML Patients"},{"description":"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.\n\nclofarabine: Given IV for 5 days\n\ncytarabine: Given IV\n\nmethotrexate: Given intrathecally or IT age based dosage\n\nlaboratory biomarker analysis","id":"EG006","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Abdominal distension"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":3,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":3,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Abdominal pain"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":3,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Acidosis"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Acute kidney injury"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":8},{"groupId":"EG001","numAffected":2,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":4,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":14,"numAtRisk":40},{"groupId":"EG006","numAffected":1,"numAtRisk":2}],"term":"Alanine aminotransferase increased"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Alkaline phosphatase increased"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":2,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Allergic reaction"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Allergic rhinitis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":2,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Alopecia"},{"organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":3,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Anaphylaxis"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Anemia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":5,"numAtRisk":10},{"groupId":"EG004","numAffected":3,"numAtRisk":7},{"groupId":"EG005","numAffected":11,"numAtRisk":40},{"groupId":"EG006","numAffected":2,"numAtRisk":2}],"term":"Anorexia"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Anxiety"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":5,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":10,"numAtRisk":40},{"groupId":"EG006","numAffected":1,"numAtRisk":2}],"term":"Aspartate aminotransferase increased"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Atelectasis"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Avascular necrosis"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":3,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Back pain"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Bladder spasm"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":1,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Blood and lymphatic system disorders - Other"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":5,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":6,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Blood bilirubin increased"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":1,"numAtRisk":2}],"term":"Bone pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Bronchospasm"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":2,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Capillary leak syndrome"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":2,"numAtRisk":7},{"groupId":"EG005","numAffected":3,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Cardiac disorders - Other"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":2,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Catheter related infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Cheilitis"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Chills"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Conjunctivitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":1,"numAtRisk":40},{"groupId":"EG006","numAffected":1,"numAtRisk":2}],"term":"Constipation"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":1,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Creatinine increased"},{"organSystem":"Endocrine disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Cushingoid"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":8},{"groupId":"EG001","numAffected":0,"numAtRisk":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":10},{"groupId":"EG004","numAffected":0,"numAtRisk":7},{"groupId":"EG005","numAffected":0,"numAtRisk":40},{"groupId":"EG006","numAffected":0,"numAtRisk":2}],"term":"Cystitis noninfective"},{"organSystem":"Metabolism and nutrition 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