{"description":"Analyses of safety (Serious Adverse Events and Other Adverse Events) were based upon the Safety Population (all subjects who were administered at least one dose of study medication) and include all data available.","eventGroups":[{"description":"CC-5013 (lenalidomide) plus oral high-dose dexamethasone","id":"EG000","otherNumAffected":177,"otherNumAtRisk":177,"seriousNumAffected":111,"seriousNumAtRisk":177,"title":"CC-5013/Dex"},{"description":"Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone","id":"EG001","otherNumAffected":175,"otherNumAtRisk":175,"seriousNumAffected":90,"seriousNumAtRisk":175,"title":"Placebo/Dex"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":177,"numEvents":12},{"groupId":"EG001","numAffected":15,"numAtRisk":175,"numEvents":18}],"term":"ABDOMINAL DISTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":27},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":15}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":12}],"term":"ABDOMINAL PAIN UPPER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":7}],"term":"AGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":177,"numEvents":139},{"groupId":"EG001","numAffected":37,"numAtRisk":175,"numEvents":44}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":177,"numEvents":39},{"groupId":"EG001","numAffected":22,"numAtRisk":175,"numEvents":23}],"term":"ANOREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":177,"numEvents":38},{"groupId":"EG001","numAffected":20,"numAtRisk":175,"numEvents":22}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":177,"numEvents":25},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":14}],"term":"APPETITE DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":177,"numEvents":63},{"groupId":"EG001","numAffected":35,"numAtRisk":175,"numEvents":51}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":43,"numAtRisk":177,"numEvents":59},{"groupId":"EG001","numAffected":47,"numAtRisk":175,"numEvents":66}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":177,"numEvents":71},{"groupId":"EG001","numAffected":38,"numAtRisk":175,"numEvents":40}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"BALANCE IMPAIRED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":6}],"term":"BLOOD CREATININE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":31},{"groupId":"EG001","numAffected":15,"numAtRisk":175,"numEvents":25}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":177,"numEvents":24},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":7}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":10},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CATARACT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":15},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":3}],"term":"CATARACT UNILATERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"CELLULITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":177,"numEvents":34},{"groupId":"EG001","numAffected":15,"numAtRisk":175,"numEvents":24}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":177,"numEvents":18},{"groupId":"EG001","numAffected":9,"numAtRisk":175,"numEvents":9}],"term":"CHEST WALL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":177,"numEvents":25},{"groupId":"EG001","numAffected":14,"numAtRisk":175,"numEvents":16}],"term":"CONFUSIONAL STATE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":177,"numEvents":99},{"groupId":"EG001","numAffected":35,"numAtRisk":175,"numEvents":43}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":23},{"groupId":"EG001","numAffected":13,"numAtRisk":175,"numEvents":15}],"term":"CONTUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":177,"numEvents":91},{"groupId":"EG001","numAffected":48,"numAtRisk":175,"numEvents":53}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":13,"numAtRisk":175,"numEvents":13}],"term":"CUSHINGOID"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":10},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"DEEP VEIN THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":177,"numEvents":26},{"groupId":"EG001","numAffected":9,"numAtRisk":175,"numEvents":10}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":177,"numEvents":31},{"groupId":"EG001","numAffected":19,"numAtRisk":175,"numEvents":19}],"term":"DEPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":177,"numEvents":174},{"groupId":"EG001","numAffected":53,"numAtRisk":175,"numEvents":85}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":177,"numEvents":102},{"groupId":"EG001","numAffected":43,"numAtRisk":175,"numEvents":54}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":177,"numEvents":18},{"groupId":"EG001","numAffected":8,"numAtRisk":175,"numEvents":10}],"term":"DRY MOUTH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":177,"numEvents":24},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":13}],"term":"DRY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":177,"numEvents":37},{"groupId":"EG001","numAffected":19,"numAtRisk":175,"numEvents":23}],"term":"DYSGEUSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":177,"numEvents":41},{"groupId":"EG001","numAffected":28,"numAtRisk":175,"numEvents":37}],"term":"DYSPEPSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":177,"numEvents":16},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":12}],"term":"DYSPNOEA EXERTIONAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":177,"numEvents":64},{"groupId":"EG001","numAffected":39,"numAtRisk":175,"numEvents":47}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":9},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ECCHYMOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":177,"numEvents":21},{"groupId":"EG001","numAffected":11,"numAtRisk":175,"numEvents":12}],"term":"EPISTAXIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":6}],"term":"ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":177,"numEvents":15},{"groupId":"EG001","numAffected":13,"numAtRisk":175,"numEvents":13}],"term":"FACE OEDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":114,"numAtRisk":177,"numEvents":191},{"groupId":"EG001","numAffected":105,"numAtRisk":175,"numEvents":164}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":177,"numEvents":18},{"groupId":"EG001","numAffected":9,"numAtRisk":175,"numEvents":10}],"term":"FLATULENCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":9},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":3}],"term":"FLUID RETENTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":12}],"term":"FLUSHING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":5}],"term":"GASTROOESOPHAGEAL REFLUX DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":177,"numEvents":79},{"groupId":"EG001","numAffected":54,"numAtRisk":175,"numEvents":66}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":177,"numEvents":22},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":6}],"term":"HERPES SIMPLEX"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":177,"numEvents":26},{"groupId":"EG001","numAffected":9,"numAtRisk":175,"numEvents":9}],"term":"HICCUPS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":177,"numEvents":20},{"groupId":"EG001","numAffected":14,"numAtRisk":175,"numEvents":14}],"term":"HOARSENESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":177,"numEvents":62},{"groupId":"EG001","numAffected":24,"numAtRisk":175,"numEvents":28}],"term":"HYPERGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"HYPERKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":177,"numEvents":17},{"groupId":"EG001","numAffected":11,"numAtRisk":175,"numEvents":15}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":177,"numEvents":22},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":5}],"term":"HYPOCALCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":177,"numEvents":91},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":17}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":177,"numEvents":34},{"groupId":"EG001","numAffected":8,"numAtRisk":175,"numEvents":8}],"term":"HYPOMAGNESAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"HYPOPHOSPHATAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":21},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":5}],"term":"INFLUENZA LIKE ILLNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":84,"numAtRisk":177,"numEvents":99},{"groupId":"EG001","numAffected":70,"numAtRisk":175,"numEvents":84}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":21},{"groupId":"EG001","numAffected":11,"numAtRisk":175,"numEvents":11}],"term":"IRRITABILITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"JOINT SWELLING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":177,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":4}],"term":"LETHARGY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":177,"numEvents":20},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"LIVER FUNCTION TESTS ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":177,"numEvents":14},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":13}],"term":"LOOSE STOOLS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":177,"numEvents":6},{"groupId":"EG001","numAffected":17,"numAtRisk":175,"numEvents":17}],"term":"MOOD ALTERATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":9},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":4}],"term":"MOOD SWINGS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":177,"numEvents":120},{"groupId":"EG001","numAffected":41,"numAtRisk":175,"numEvents":61}],"term":"MUSCLE CRAMP"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":6}],"term":"MUSCLE SPASMS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":177,"numEvents":37},{"groupId":"EG001","numAffected":29,"numAtRisk":175,"numEvents":31}],"term":"MUSCLE WEAKNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":9},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":7}],"term":"MUSCULOSKELETAL STIFFNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":177,"numEvents":22},{"groupId":"EG001","numAffected":22,"numAtRisk":175,"numEvents":26}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":20},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":8}],"term":"NASAL CONGESTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":177,"numEvents":82},{"groupId":"EG001","numAffected":11,"numAtRisk":175,"numEvents":13}],"term":"NASOPHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":177,"numEvents":90},{"groupId":"EG001","numAffected":55,"numAtRisk":175,"numEvents":79}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":177,"numEvents":25},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":13}],"term":"NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":87,"numAtRisk":177,"numEvents":348},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":22}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":177,"numEvents":20},{"groupId":"EG001","numAffected":13,"numAtRisk":175,"numEvents":16}],"term":"NIGHT SWEATS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":177,"numEvents":6},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":11}],"term":"NOCTURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":177,"numEvents":22},{"groupId":"EG001","numAffected":18,"numAtRisk":175,"numEvents":22}],"term":"OEDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":177,"numEvents":87},{"groupId":"EG001","numAffected":42,"numAtRisk":175,"numEvents":54}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":177,"numEvents":18},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":11}],"term":"ORAL CANDIDIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":12},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ORAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":177,"numEvents":38},{"groupId":"EG001","numAffected":13,"numAtRisk":175,"numEvents":23}],"term":"PAIN IN LIMB"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":23},{"groupId":"EG001","numAffected":19,"numAtRisk":175,"numEvents":25}],"term":"PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":177,"numEvents":31},{"groupId":"EG001","numAffected":18,"numAtRisk":175,"numEvents":23}],"term":"PARAESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":177,"numEvents":33},{"groupId":"EG001","numAffected":19,"numAtRisk":175,"numEvents":23}],"term":"PERIPHERAL NEUROPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":177,"numEvents":21},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":5}],"term":"PERIPHERAL SWELLING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":177,"numEvents":55},{"groupId":"EG001","numAffected":18,"numAtRisk":175,"numEvents":22}],"term":"PHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":177,"numEvents":31},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":4}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":7}],"term":"PRODUCTIVE COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":30},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":11}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":177,"numEvents":85},{"groupId":"EG001","numAffected":35,"numAtRisk":175,"numEvents":48}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":177,"numEvents":83},{"groupId":"EG001","numAffected":28,"numAtRisk":175,"numEvents":30}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":12},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":6}],"term":"RHINORRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":15},{"groupId":"EG001","numAffected":14,"numAtRisk":175,"numEvents":16}],"term":"RIGORS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":177,"numEvents":41},{"groupId":"EG001","numAffected":11,"numAtRisk":175,"numEvents":14}],"term":"SINUSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":10},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":8}],"term":"SOMNOLENCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":177,"numEvents":23},{"groupId":"EG001","numAffected":14,"numAtRisk":175,"numEvents":15}],"term":"STOMATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":177,"numEvents":21},{"groupId":"EG001","numAffected":10,"numAtRisk":175,"numEvents":11}],"term":"SWEATING INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":177,"numEvents":16},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"SYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":177,"numEvents":83},{"groupId":"EG001","numAffected":19,"numAtRisk":175,"numEvents":28}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"TOOTHACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":177,"numEvents":44},{"groupId":"EG001","numAffected":12,"numAtRisk":175,"numEvents":15}],"term":"TREMOR"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":177,"numEvents":123},{"groupId":"EG001","numAffected":39,"numAtRisk":175,"numEvents":59}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":177,"numEvents":13},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":8}],"term":"URINARY FREQUENCY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":177,"numEvents":31},{"groupId":"EG001","numAffected":7,"numAtRisk":175,"numEvents":13}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":177,"numEvents":79},{"groupId":"EG001","numAffected":30,"numAtRisk":175,"numEvents":56}],"term":"VISION BLURRED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":177,"numEvents":32},{"groupId":"EG001","numAffected":22,"numAtRisk":175,"numEvents":24}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":177,"numEvents":24},{"groupId":"EG001","numAffected":8,"numAtRisk":175,"numEvents":8}],"term":"WEIGHT DECREASED"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ABSCESS INTESTINAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ACETABULUM FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ACQUIRED BRONCHOMALACIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ACUTE MYOCARDIAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ADRENAL INSUFFICIENCY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ANAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ANGINA PECTORIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"AORTIC STENOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"APPENDICEAL ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"APPENDICITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ARTERIAL THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ARTERIOSPASM CORONARY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ARTHRITIS BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ASTHENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":177,"numEvents":11},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ATRIAL FLUTTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"AZOTAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BLINDNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BLINDNESS TRANSIENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BLOOD BILIRUBIN ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BLOOD CREATININE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BRONCHIOLOALVEOLAR CARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"BRONCHOSPASM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CARDIAC ARREST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CARDIAC FAILURE CONGESTIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CARDIO-RESPIRATORY ARREST"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CATARACT UNILATERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CATHETER RELATED INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CATHETER SITE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CELLULITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CELLULITIS STAPHYLOCOCCAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CEREBELLAR INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CEREBRAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CEREBRAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CEREBROVASCULAR ACCIDENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CHEST WALL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"CHRONIC OBSTRUCTIVE AIRWAYS DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CLOSTRIDIUM COLITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"COLITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"COLITIS PSEUDOMEMBRANOUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"CONFUSIONAL STATE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"CONVULSIONS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"CORONARY ARTERY DISEASE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":177,"numEvents":18},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":6}],"term":"DEEP VEIN THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":177,"numEvents":9},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"DEHYDRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"DELIRIUM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"DELUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DEPRESSED LEVEL OF CONSCIOUSNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DERMATITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"DIABETES WITH HYPEROSMOLARITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DIABETIC KETOACIDOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DIVERTICULAR PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DIVERTICULITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DIVERTICULUM INTESTINAL HAEMORRHAGIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"DIZZINESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DYSPNOEA EXACERBATED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"EMPHYSEMATOUS BULLA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"ENCEPHALITIS HERPES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ENTEROBACTER BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"EPISTAXIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"FANCONI SYNDROME ACQUIRED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":177,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"FEBRILE NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"FEMUR FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"FIBULA FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"FLUID OVERLOAD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"GASTRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"GASTROENTERITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"GINGIVAL BLEEDING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HAEMATURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HAEMOGLOBIN DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HAEMORRHOIDAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HEPATIC FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HEPATITIS TOXIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HERPES VIRAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HIP FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPERAMMONAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"HYPERCALCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":175,"numEvents":4}],"term":"HYPERGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HYPERKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HYPERTENSIVE CRISIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPERVISCOSITY SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPOALBUMINAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPOCALCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HYPOGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"HYPOMAGNESAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":24},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"HYPOXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"INGUINAL HERNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"INTERNATIONAL NORMALISED RATIO INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"INTERSTITIAL PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"INTESTINAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"INTRACRANIAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"INTRACRANIAL VENOUS SINUS THROMBOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"LARGE INTESTINAL PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"LEUKAEMIA PLASMACYTIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"LEUKOENCEPHALOPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"LIVER FUNCTION TESTS ABNORMAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"LOBAR PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"LOWER GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"LUNG NODULE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"LYMPHADENOPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"MAJOR DEPRESSIVE DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":175,"numEvents":3}],"term":"MENTAL STATUS CHANGES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"METABOLIC ACIDOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"METASTASES TO LIVER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"MULTIPLE FRACTURES"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"MUSCLE WEAKNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"MYELODYSPLASTIC SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"MYOCARDIAL INFARCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"MYOPATHY STEROID"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"NEUTROPENIC SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"ORTHOSTATIC HYPOTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"OSTEOMYELITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"OSTEONECROSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"PANCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"PERIPHERAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PERIPHERAL ISCHAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PLASMACYTOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PLEURAL EFFUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMOCOCCAL BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMOCYSTIS CARINII PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMONIA BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMONIA CYTOMEGALOVIRAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"PNEUMONIA FUNGAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":177,"numEvents":39},{"groupId":"EG001","numAffected":15,"numAtRisk":175,"numEvents":17}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"PNEUMONIA PRIMARY ATYPICAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMONIA STAPHYLOCOCCAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PNEUMONIA STREPTOCOCCAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"PSYCHOTIC DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":177,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"PULMONARY OEDEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":177,"numEvents":8},{"groupId":"EG001","numAffected":6,"numAtRisk":175,"numEvents":8}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"RADIUS FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"RENAL FAILURE ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":175,"numEvents":5}],"term":"RENAL FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"RENAL TUBULAR NECROSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"RESPIRATORY FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"RETINAL DETACHMENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"RETINAL VEIN OCCLUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"RIB FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"SINUS TACHYCARDIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SINUSITIS FUNGAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SINUSITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SKIN DESQUAMATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SKIN DISCOLOURATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SMALL INTESTINAL OBSTRUCTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SOMNOLENCE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"SPINAL COMPRESSION FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"SPINAL CORD COMPRESSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SQUAMOUS CELL CARCINOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SQUAMOUS CELL CARCINOMA OF SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"STAPHYLOCOCCAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"STREPTOCOCCAL BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"STREPTOCOCCAL SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SUBACUTE ENDOCARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SUBDURAL HAEMATOMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SUICIDE ATTEMPT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SUPERIOR VENA CAVAL OCCLUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"SYNCOPE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"SYSTEMIC INFLAMMATORY RESPONSE SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"TACHYCARDIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":177,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":175,"numEvents":2}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"TOOTH ABSCESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"TRANSIENT ISCHAEMIC ATTACK"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":177,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":177,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"UROSEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"VASCULAR GRAFT OCCLUSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"VIRAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"VOMITING"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":177,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":175,"numEvents":0}],"term":"WHITE BLOOD CELL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (5.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":177,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":175,"numEvents":1}],"term":"WRIST FRACTURE"}],"timeFrame":"Up to 254 weeks (median=48 weeks; mean=77 weeks)"}