{"eventGroups":[{"description":"40 mg Dexamethasone orally on days 1, 8, 15, 22.","id":"EG000","otherNumAffected":33,"otherNumAtRisk":33,"seriousNumAffected":15,"seriousNumAtRisk":33,"title":"Treatment"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":33,"numEvents":174}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":33,"numEvents":22}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":33,"numEvents":31}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Oesophagoscopy abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33,"numEvents":6}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":33,"numEvents":59}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":33,"numEvents":217}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":2}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33,"numEvents":5}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Immune system disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":6}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Tooth infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":2}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":3}],"term":"Bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":33,"numEvents":109}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":33,"numEvents":121}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":33,"numEvents":134}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Blood glucose increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Serum albumin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Serum sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":33,"numEvents":36}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Osteoporosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":33,"numEvents":52}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Syncope vasovagal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":4}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":3}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":33,"numEvents":9}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Gynecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Respiratory disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":33,"numEvents":34}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Thrombosis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":33,"numEvents":6}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Gastrointestinal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Leukocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":5}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Muscle weakness lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Rash desquamating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":33,"numEvents":3}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 10","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Vascular disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Sudden Death"}]}