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(4.03)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":52,"numEvents":42}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":52,"numEvents":33}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Skin hyperpigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":6}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":52,"numEvents":71}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":52,"numEvents":17}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular 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(4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Cardiac disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Myocarditis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders and administration site conditions","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders and administration site conditions","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Encephalitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":5}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Injury, poisoning and procedural complications - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Urine output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Spasticity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Thromboembolic event"}],"timeFrame":"Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 6 years."}