{"eventGroups":[{"description":"All participants enrolled.\n\n5-Azacitidine: Administered on Days 1-7 of each Cycle.\n\nSubcutaneous administration:\n\nTo provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.\n\nThe 5-azacitidine suspension is administered subcutaneously.\n\nIntravenous Administration:\n\n5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":2,"seriousNumAtRisk":11,"title":"Arm 1 - 5-Azacitidine"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Abdominal Cramping"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"abdominal pain"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":22}],"term":"Anemia"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"ankle sprain"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"anorexia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"anthralgia"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":3}],"term":"back pain"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Bacteremia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"bloating"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"bloody discharge from urethra"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"bone pain"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Broken Blood Vessel of the Eye"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4}],"term":"bruising"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"cellulitis"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"chest lesion"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"chest pain"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"chills"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"chloroma"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"cold sweats"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"cold symptoms"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":11,"numEvents":10}],"term":"Constipation"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Cooler Lower Extremeties"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Cough"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"decreased neutrophil"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Dehydration"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Depression"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"dermatitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Diarrhea"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Dizziness"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"dry mouth"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"dry nose"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Dysgeusia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"dyspepsia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"dysphagia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"dyspnea"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":3}],"term":"Ecchymoses"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"epigastric pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Epistaxis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"erythmea"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"eye irratation"},{"organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"eye swelling"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"face burning"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4}],"term":"Fall"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":5}],"term":"Fatigue"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"flank pain"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"flu like symptoms"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"foot edema"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"frequent urination"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"headache"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hematochezia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"hematoma"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hemoptysis"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"hip pain"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hot Flashes"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"hyperglycema"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypomagnesemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"hypotension"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hypoxia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"increased creatinine"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":5}],"term":"injection reaction"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"insomnia"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"itching"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"labyrinthitis"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":3}],"term":"laceration"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"leg pain"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"leucocytosis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":26}],"term":"Leukopenia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"limited movement of limb"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"loose stool"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"malaise"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"mouth sores"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Muscle Cramps"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"muscle weakness"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Nasal Congestion"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11,"numEvents":11}],"term":"Nausea"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":3}],"term":"neuropathy"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":59}],"term":"neutropenia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"neutropenic fever"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Night Sweats"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Nightmares"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Nose Sore"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Occasional palpitations"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"oral herpes lesion"},{"organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"parovaria cyst"},{"organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"pelvic pain"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Pneumonia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"port site infection"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Prostatitis"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":3}],"term":"rash"},{"organSystem":"Ear and labyrinth disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"ear lesion"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Rhinitis"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"rhinovirus"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"scalp lesions"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"seizures"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"shin lesion"},{"organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Sinus Infection"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Sleep apnea"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"sore throat"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"stomach pain"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":2}],"term":"syncope"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"tachycardia"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"tendinitis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11,"numEvents":40}],"term":"Thrombocytopenia"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"tooth infection"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"tooth pain"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"torn ligament"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"tremor"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2}],"term":"Upper Respiratory Infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Urinary Tract Infection"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"viral conjunctivitis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3}],"term":"Vomiting"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Weight Gain"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"wound treatment"}],"seriousEvents":[{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Fatigue"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"leukocytosis"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Mucositis"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Thrombocytopenia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"Hematochezia"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"seizure"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1}],"term":"wound treatment"}]}