{"description":"Maximum grade toxicity by type was first calculated within each arm. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term. The analysis population is comprised of the subset of participants who underwent surgical biopsy.","eventGroups":[{"deathsNumAffected":29,"deathsNumAtRisk":30,"description":"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).\n\nRadiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles","id":"EG000","otherNumAffected":30,"otherNumAtRisk":30,"seriousNumAffected":8,"seriousNumAtRisk":30,"title":"Cohort 1 MGMT-/EGFR-"},{"deathsNumAffected":14,"deathsNumAtRisk":14,"description":"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).\n\nRadiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles","id":"EG001","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":9,"seriousNumAtRisk":14,"title":"Cohort 2 MGMT-/EGFR+"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).\n\nRadiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Cohort 3: MGMT+/EGFR-"},{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Protocol treatment lasts approximately 52 weeks including a 4-week interim period once radiation therapy is completed and a maintenance phase (cycle duration=28 days).\n\nRadiation therapy: Given in 180 cGy fractions to a total dose of 59.4 + 1.8 Gy/-5.4 Gy for approximately 7 weeks beginning 7-21 days after biopsy Bevacizumab: Administered intravenously at 10 mg/kg beginning no sooner than 21 days from biopsy and every 14 days concurrent with radiation therapy, through the interim period and for up to 10 maintenance cycles Erlotinib: Administered orally at 85 mg/m2 daily continuously during radiation therapy, through the interim period and for up to 10 maintenance cycles Temozolomide: Administered orally at 90 mg/m2/day continuously during radiation therapy, held through the interim period and then 200 mg/m2/day for 5 days for up to 10 maintenance cycles","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Cohort 4. MGMT+/EGFR+"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Abdominal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Abducens nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":30},{"groupId":"EG001","numAffected":6,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Allergic rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Anal hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Bladder spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Blood and lymphatic system disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Bronchospasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Bullous dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Cardiac disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"CD4 lymphocytes decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Conjunctivitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":3,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Cushingoid"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Cystitis noninfective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dental caries"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dermatitis radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":6,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":8,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Ear and labyrinth disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Encephalitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Esophageal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"External ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"External ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Eye disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Eyelid function disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Facial muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Facial nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Gastrointestinal disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Gastrointestinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Glossopharyngeal nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":30},{"groupId":"EG001","numAffected":7,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hirsutism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypercalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":30},{"groupId":"EG001","numAffected":6,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypoglossal nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Infections and infestations - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Intracranial hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Investigations - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"IVth nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Joint range of motion decreased cervical spine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Laryngeal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Mediastinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Metabolism and nutrition disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Middle ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Movements involuntary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Muscle weakness left-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Muscle weakness right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Muscle weakness upper limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Neck edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Nervous system disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Nystagmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Oculomotor nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Optic nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Otitis externa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Penile pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Perineal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Personality change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Postoperative hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pyramidal tract syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Renal and urinary disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Renal calculi"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Respiratory, thoracic and mediastinal disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Salivary gland fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":2,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin atrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin hypopigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin induration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Spasticity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Stomach pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Trigeminal nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":5,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urinary urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Urine discoloration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Vagus nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":30},{"groupId":"EG001","numAffected":9,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":3,"numAtRisk":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":30},{"groupId":"EG001","numAffected":4,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":30},{"groupId":"EG001","numAffected":3,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Wound infection"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":1,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"CD4 lymphocytes decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Dysphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":30},{"groupId":"EG001","numAffected":2,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Muscle weakness left-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Muscle weakness right-sided"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Skin and subcutaneous tissue disorders-Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Spasticity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":30},{"groupId":"EG001","numAffected":0,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":30},{"groupId":"EG001","numAffected":1,"numAtRisk":14},{"groupId":"EG002","numAffected":0,"numAtRisk":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Wound infection"}],"timeFrame":"Adverse events were routinely throughout treatment. Treatment duration was a median of 6.4 months (range 0.4-13.4 months) in this study cohort."}