{"eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Nivolumab and dose escalation of Cetuximab.\n\nLead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\\^2; Nivolumab 240 mg.\n\nNivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.\n\nCetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Phase I - Lead in"},{"deathsNumAffected":35,"deathsNumAtRisk":44,"description":"Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"EG001","otherNumAffected":43,"otherNumAtRisk":44,"seriousNumAffected":19,"seriousNumAtRisk":44,"title":"Phase II- Cohort A"},{"deathsNumAffected":33,"deathsNumAtRisk":48,"description":"Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC\n\nParticipants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\\^2 or 250 mg/m\\^2 as outlined in the treatment arms.","id":"EG002","otherNumAffected":45,"otherNumAtRisk":48,"seriousNumAffected":19,"seriousNumAtRisk":48,"title":"Phase II - Cohort B"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":5}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":13}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Alkalosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Allergic rhinitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":14,"numAtRisk":48,"numEvents":47}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":8},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":10}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Arthritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":7}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":11,"numAtRisk":48,"numEvents":20}],"term":"Aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Atelectasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":3}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Bullous dermatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Chest pain - cardiac"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Chest wall pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Conjunctivitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":16,"numAtRisk":44,"numEvents":17},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":7}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":7}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":16},{"groupId":"EG002","numAffected":12,"numAtRisk":48,"numEvents":22}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":11}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Cardiac disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Cognitive disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Dry eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":11}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":9,"numAtRisk":44,"numEvents":10},{"groupId":"EG002","numAffected":23,"numAtRisk":48,"numEvents":28}],"term":"Dry Skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Dysarthria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Dysphasia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":9,"numAtRisk":44,"numEvents":13},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":19}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Ear and labyrinth disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Edema face"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Endocrine disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":5}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Erectile dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Erythema multiforme"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":7}],"term":"Eye disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Eye infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Facial muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Facial pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":12,"numAtRisk":44,"numEvents":15},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":9}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG001","numAffected":17,"numAtRisk":44,"numEvents":29},{"groupId":"EG002","numAffected":15,"numAtRisk":48,"numEvents":28}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Floaters"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":10,"numAtRisk":44,"numEvents":11},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":11}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Gingival pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Hallucinations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":8},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hearing impaired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hemoglobin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hiccups"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hirsutism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Hoarseness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":11,"numAtRisk":48,"numEvents":54}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hypermagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":15},{"groupId":"EG002","numAffected":8,"numAtRisk":48,"numEvents":81}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hyperthyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":10},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":8}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Hypoglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":11,"numAtRisk":48,"numEvents":18}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":16},{"groupId":"EG002","numAffected":16,"numAtRisk":48,"numEvents":49}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":10},{"groupId":"EG002","numAffected":8,"numAtRisk":48,"numEvents":11}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":14},{"groupId":"EG002","numAffected":14,"numAtRisk":48,"numEvents":29}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":9}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":6,"numAtRisk":44,"numEvents":11},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":11}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":13}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Injury, poisoning and procedural complications - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"INR increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":8,"numAtRisk":48,"numEvents":9}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Intraoperative renal injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":5}],"term":"Investigations - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Joint range of motion decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Laryngeal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Leukocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":6}],"term":"Localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Lymphedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":44,"numEvents":8},{"groupId":"EG002","numAffected":11,"numAtRisk":48,"numEvents":34}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Metabolism and nutrition disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Middle ear inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":10}],"term":"Mucosal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":7}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Muscle weakness lower limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Muscle weakness upper limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":9}],"term":"Musculoskeletal and connective tissue disorder - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Nail infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Nail loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Nail ridging"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":10}],"term":"Nasal congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":9,"numAtRisk":44,"numEvents":13},{"groupId":"EG002","numAffected":11,"numAtRisk":48,"numEvents":18}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Oral dysesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Oral hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Oral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Otitis externa"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Otitis media"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":8},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":5}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":5}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pain of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Palmar-plantar erythrodysesthesia syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":25}],"term":"Papulopustular rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":6,"numAtRisk":48,"numEvents":7}],"term":"Paresthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":11},{"groupId":"EG002","numAffected":12,"numAtRisk":48,"numEvents":30}],"term":"Paronychia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Pericardial tamponade"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Pharyngeal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pharyngeal mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pharyngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Postnasal drip"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Proctitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Productive cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":8,"numAtRisk":44,"numEvents":8},{"groupId":"EG002","numAffected":10,"numAtRisk":48,"numEvents":13}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3,"numEvents":5},{"groupId":"EG001","numAffected":21,"numAtRisk":44,"numEvents":36},{"groupId":"EG002","numAffected":31,"numAtRisk":48,"numEvents":63}],"term":"Rash acneiform"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":10}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":9,"numAtRisk":48,"numEvents":15}],"term":"Respiratory, thoracic and mediastinal disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Restlessness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Sinus bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":9,"numAtRisk":44,"numEvents":15},{"groupId":"EG002","numAffected":19,"numAtRisk":48,"numEvents":34}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":44,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Small intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Somnolence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Sore throat"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":3}],"term":"Stomach pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Surgical and medical procedures - Other, specify"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Tinnitus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":4}],"term":"Toothache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Tracheal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Tracheitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Tracheostomy site bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Trismus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Urinary frequency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Urinary incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":6}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Urinary tract pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Vascular disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Vertigo"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Voice alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":44,"numEvents":7},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":20}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":11}],"term":"Weight gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":44,"numEvents":9},{"groupId":"EG002","numAffected":8,"numAtRisk":48,"numEvents":15}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Wheezing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":48,"numEvents":8}],"term":"White blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Wound dehiscence"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Renal and urinary disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":5},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Respiratory failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Death, NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"PEG tube re-placement","organSystem":"Surgical and medical procedures","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Surgical and medical procedures - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Disease progression","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":6,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Neoplasms benign, malignant and unspecified-Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Atrial fibrilation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Pharyngeal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":44,"numEvents":6},{"groupId":"EG002","numAffected":7,"numAtRisk":48,"numEvents":11}],"term":"Aspiration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Tracheal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Bacterial pneumonia","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Infections and Infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Lethargy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Infusion related reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hypoglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hallucinations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Parasthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Esophageal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Ventricular arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Myocarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Gastric ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Small intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Hypernatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Feeding tube displaced by patient","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Injury, poisoning and procedural complications -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Intra-abdominal infection","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Gastrointestinal disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"PEG tube malfunction/redness","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"G tube dysfunction","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Duodenitis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Gastrointestinal disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Sudden death, NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"tracheostomy obstruction by mucous","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":44,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":48,"numEvents":0}],"term":"Respiratory, thoracic and mediastinal disorders -Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Tracheitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":48,"numEvents":3}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Pericardial tamponade"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":44,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Abdominal pain"}],"timeFrame":"Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable."}