{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Oral lenalidomide 25mg twice daily x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG000","otherNumAffected":1,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Phase 1 Dose Level 1"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Oral lenalidomide 25mg qAM, 50mq qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Phase 1 Dose Level 2"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Oral lenalidomide 50mg qAM, 75mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1 Dose Level 3"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Oral lenalidomide 75mg qAM, 100mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG003","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"Phase 1 Dose Level 4"},{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Oral lenalidomide 100mg qAM, 150mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG004","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":3,"seriousNumAtRisk":6,"title":"Phase 1 Dose Level 5"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG005","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1 Dose Level 6"},{"deathsNumAffected":0,"deathsNumAtRisk":30,"description":"Phase 2 MTD, oral lenalidomide 150mg qAM, 200mg qPM x 5 days (designated as days -5 to -1).\n\nOn days-2 and -1, all patients will receive 100mg/m2 of intravenous melphalan once daily for a total of 2 doses (200mg/m2total). After a period of 24-72 hours has elapsed from the last melphalan dose (designated as Day 0) each patient will receive infusion of at least 2.0 x 106/kg of autologous CD34+ stem cells.\n\nMaintenance lenalidomide will begin at Day +100 at a dose of 25 mg/day, orally for 1-21 days followed by a 7-day rest period (28 day cycles).\n\nlenalidomide: daily dose dependent on dose-escalation schedule\n\nmelphalan: 100 mg/m2 given Days -2 and -1","id":"EG006","otherNumAffected":29,"otherNumAtRisk":30,"seriousNumAffected":8,"seriousNumAtRisk":30,"title":"Phase 2 MTD"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Abdominal Distention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":11,"numAtRisk":30,"numEvents":11}],"term":"Activated PTT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Acute kidney Injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Acute renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":20,"numAtRisk":30,"numEvents":50}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":13},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":16,"numAtRisk":30,"numEvents":35}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Acute otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":4}],"term":"Amnesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":8},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":4},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":8},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG006","numAffected":28,"numAtRisk":30,"numEvents":59}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":19,"numAtRisk":30,"numEvents":23}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":6,"numAtRisk":30,"numEvents":12}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":11,"numAtRisk":30,"numEvents":13}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":18,"numAtRisk":30,"numEvents":46}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Atrial Fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":13},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":14,"numAtRisk":30,"numEvents":20}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Leukopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":8},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":29,"numAtRisk":30,"numEvents":96}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":10,"numAtRisk":30,"numEvents":20}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"eGFR decreased","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":7}],"term":"Chronic kidney disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Concentration impairement"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG006","numAffected":8,"numAtRisk":30,"numEvents":16}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":8}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"CPK increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":8,"numAtRisk":30,"numEvents":13}],"term":"Creatinine increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":5}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":9},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":17},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":12},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":5},{"groupId":"EG006","numAffected":25,"numAtRisk":30,"numEvents":53}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":5}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Dry eyes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":6}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":4}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":6,"numAtRisk":30,"numEvents":6}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":7}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":8,"numAtRisk":30,"numEvents":9}],"term":"Edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":5},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Edema limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Erectile dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hordeolum","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":14},{"groupId":"EG004","numAffected":5,"numAtRisk":6,"numEvents":8},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":5},{"groupId":"EG006","numAffected":23,"numAtRisk":30,"numEvents":38}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":7}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":5}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":5}],"term":"Flu-like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Gait alteration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Gastroesophageal reflux"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Odynophagia","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":5}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Gastropharesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":4},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Gum infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":7}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Hearing impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Herpes simplex reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":2}],"term":"Hiccups"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":8},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":5},{"groupId":"EG004","numAffected":5,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":4},{"groupId":"EG006","numAffected":29,"numAtRisk":30,"numEvents":68}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":8}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":9}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Hyperlipidemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":8}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":11}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":27,"numAtRisk":30,"numEvents":50}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":10},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":7},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":10},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":12},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":28,"numAtRisk":30,"numEvents":84}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":10},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":7},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":20},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":15,"numAtRisk":30,"numEvents":24}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":7},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":25,"numAtRisk":30,"numEvents":32}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":18},{"groupId":"EG004","numAffected":5,"numAtRisk":6,"numEvents":9},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG006","numAffected":21,"numAtRisk":30,"numEvents":62}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":4},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":13,"numAtRisk":30,"numEvents":21}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":5}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":8},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Infusion-Related Reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":21,"numAtRisk":30,"numEvents":28}],"term":"INR increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":10},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":12,"numAtRisk":30,"numEvents":24}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Intracranial Hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":18},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":29,"numAtRisk":30,"numEvents":75}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":3}],"term":"Lymphocyte count increase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":4}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Metabolism and nutrition disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":5}],"term":"Muscle cramp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Nail infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":8},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":4},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":5,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":21,"numAtRisk":30,"numEvents":38}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":15},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":10},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":18},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":26},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":9},{"groupId":"EG006","numAffected":29,"numAtRisk":30,"numEvents":113}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Non-cardiac Chest Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":7},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":17,"numAtRisk":30,"numEvents":42}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":13,"numAtRisk":30,"numEvents":15}],"term":"Peripheral neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Phlebitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":4,"numEvents":8},{"groupId":"EG002","numAffected":3,"numAtRisk":3,"numEvents":6},{"groupId":"EG003","numAffected":3,"numAtRisk":4,"numEvents":15},{"groupId":"EG004","numAffected":6,"numAtRisk":6,"numEvents":9},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":29,"numAtRisk":30,"numEvents":75}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Post nasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":5},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":5,"numAtRisk":30,"numEvents":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":9,"numAtRisk":30,"numEvents":13}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Nocturia","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Renal and urinary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Tachypnea","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":4}],"term":"Rhinitis Infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Scalp pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Shingles"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Sinus disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Skin lesion","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":3}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":4}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hernia repair","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Thrush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":30,"numEvents":5}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":7},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":10},{"groupId":"EG004","numAffected":5,"numAtRisk":6,"numEvents":9},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":19,"numAtRisk":30,"numEvents":42}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":4,"numAtRisk":30,"numEvents":4}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":3,"numAtRisk":6,"numEvents":3},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hyperviscosity","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Vascular disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Vasovagal reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"HHV6 Viremia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":4,"numAtRisk":6,"numEvents":6},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":8,"numAtRisk":30,"numEvents":13}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Watering eyes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":7,"numAtRisk":30,"numEvents":11}],"term":"Weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":6,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":11,"numAtRisk":30,"numEvents":11}],"term":"Weight loss"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Hip pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Diverticulitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Gastroenteritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Umbilical abscess","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":30,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Myocardiac Infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Basal cell carcinoma, lip","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":6,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":30,"numEvents":1}],"term":"Urinary Incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Urinary Retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":6,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":30,"numEvents":0}],"term":"Ventricular Tachycardia"}],"timeFrame":"Adverse events presented were collected for an average of 3 years"}