{"eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":42,"description":"Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks\n\nPembrolizumab","id":"EG000","otherNumAffected":40,"otherNumAtRisk":42,"seriousNumAffected":19,"seriousNumAtRisk":42,"title":"Soft Tissue Sarcoma"},{"deathsNumAffected":2,"deathsNumAtRisk":42,"description":"Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \\[de-differentiated or mesenchymal\\]. Pembrolizumab will be administered at 200 mg intravenously every 3 weeks\n\nPembrolizumab","id":"EG001","otherNumAffected":42,"otherNumAtRisk":42,"seriousNumAffected":15,"seriousNumAtRisk":42,"title":"Bone Sarcoma"},{"deathsNumAffected":2,"deathsNumAtRisk":60,"description":"Patients with the following types of soft tissue sarcoma: Undifferentiated pleomorphic sarcoma (UPS) and de-differentiated liposarcoma (LPS). Pembrolizumab will be administered at 200 mg intravenously every 3 weeks","id":"EG002","otherNumAffected":58,"otherNumAtRisk":60,"seriousNumAffected":17,"seriousNumAtRisk":60,"title":"Expansion"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":42,"numEvents":9},{"groupId":"EG001","numAffected":8,"numAtRisk":42,"numEvents":8},{"groupId":"EG002","numAffected":21,"numAtRisk":60,"numEvents":21}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"Blood and Lymphatic Systems Disorder, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Febrile Neuropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"Leukocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Cardiac disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"palpitations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Sinus Bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"Sinus Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Ventricular Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Ear and Labyrinth disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Endocrine Disorders-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Hyperparathyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"Hyperthyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":60,"numEvents":7}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":42,"numEvents":7},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"flatulance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"gastrointestinal disorders-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"tooth infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"vaginal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Bruising"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":42,"numEvents":7},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"activated partial thromboplastin time prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"Alanine aminotranferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":12,"numAtRisk":42,"numEvents":12},{"groupId":"EG002","numAffected":7,"numAtRisk":60,"numEvents":7}],"term":"Alkaline Phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":7,"numAtRisk":42,"numEvents":7},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"INR increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG002","numAffected":10,"numAtRisk":60,"numEvents":10}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"hypoalbumenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":42,"numEvents":8},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":42,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"chest wall pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":7,"numAtRisk":60,"numEvents":7}],"term":"musculoskeletal and connective tissue disorder-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"tumor pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"nervous system disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"neuralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Proteinuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"URINARY URGENCY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":42,"numEvents":9},{"groupId":"EG001","numAffected":7,"numAtRisk":42,"numEvents":7},{"groupId":"EG002","numAffected":7,"numAtRisk":60,"numEvents":7}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Laryngeal hemmorhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Postnasal drip"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"respiratory, thoracic, and mediastinal disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"erythmea multiforme"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"Pruritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":7,"numAtRisk":60,"numEvents":7}],"term":"rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Hot flashes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"photophobia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Dental caries"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Gastric ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"gastroesophogeal reflux"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":42,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":9,"numAtRisk":60,"numEvents":9}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"rectal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":60,"numEvents":6}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"flu like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":5,"numAtRisk":60,"numEvents":5}],"term":"general disorders-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Hypothermia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"malaise"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"serum sickness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"infections and infestations-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"papulopustular rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":60,"numEvents":4}],"term":"upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"CPK increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"investigations-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"lymphocyte count increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"white blood cell decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":42,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":60,"numEvents":8}],"term":"anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"buttock pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"flank pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"joint effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"joint range of motion decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":42,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"soft tissue necrosis upper limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"neoplasms, benign, malignant, and unspecified"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"dysesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Paresthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":42,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"presyncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"psychiatric disorders-other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"suicidal ideation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"allergic rhinitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"productive cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"sore throat"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"rash acneiform"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":42,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"skin and subcutaneous tissue disorders"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Bronchopulmonary hemmorhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Duodenal Perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":60,"numEvents":2}],"term":"Neoplasms, benign, malignant and unspecified"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Laryngeal hemmorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Pleural Effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Nervous system disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Acute kidney inury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Renal and urinary disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Vascular disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Cardiac disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Ventricular Tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":42,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Adrenal Insufficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Blurred Vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Colonic Obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Colonic Stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":60,"numEvents":3}],"term":"General Disorders and Administration site conditions"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Immune system disorders, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Urinary Tract Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":42,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":60,"numEvents":0}],"term":"Bone Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Musculoskeletal and connective tissue disorder, other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":42,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":60,"numEvents":1}],"term":"Myositis"}],"timeFrame":"Adverse Event data is collected beginning from the time of treatment through 30 days following cessation of treatment or the initiation of a new anti-cancer therapy, whichever is earlier."}