{"eventGroups":[{"description":"Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"Phase I Dose Finding"},{"description":"Standard treatment of sirolimus and tacrolimus as GvHD prophylaxis with sirolimus (target plasma drug level of 5-10 ng/ml) and lenalidomide (15 mg daily) as post-transplant maintenance","id":"EG001","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":8,"seriousNumAtRisk":11,"title":"Phase II"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Ear pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hyperthyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Dry eye"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":6,"numAtRisk":11}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Anal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":10,"numAtRisk":11}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Gastrointestinal disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Lip pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":5,"numAtRisk":11}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":10,"numAtRisk":11}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Oral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Rectal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":7,"numAtRisk":11}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Edema face"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Facial pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3},{"groupId":"EG001","numAffected":8,"numAtRisk":11}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Abdominal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Bronchial infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Eye infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Gum infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":7,"numAtRisk":11}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Laryngitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Otitis media"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3},{"groupId":"EG001","numAffected":5,"numAtRisk":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3},{"groupId":"EG001","numAffected":8,"numAtRisk":11}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3},{"groupId":"EG001","numAffected":8,"numAtRisk":11}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"INR increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hypercalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hypermagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hyperuricemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Metabolism and nutrition disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Chest wall pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Musculoskeletal and connective tissue disorder - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":6,"numAtRisk":11}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Nervous system disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Paresthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Peripheral motor neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Sinus pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Agitation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hallucinations"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Bladder spasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Renal and urinary disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Urinary tract pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Erectile dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Nasal congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Postnasal drip"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Sore throat"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Pain of skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Scalp pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Skin hyperpigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":11}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Atrial flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Cardiac arrest"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Cardiac disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Chest pain - cardiac"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Heart failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Sinus bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Ventricular tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hearing impaired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hyperthyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Blurred vision"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Keratitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Gastrointestinal disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":11}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Oral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Infections and infestations - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Blood bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Chest wall pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Generalized muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Muscle weakness lower limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Nervous system disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Delusions"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Renal and urinary disorders - Other"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Urinary tract pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":11}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":11}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (12.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":11}],"term":"Thromboembolic event"}],"timeFrame":"up to 3 years"}