{"description":"All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":140,"description":"All subjects that received at least one dose of DFMO. Since both arms received the same exact treatment, they were combined into one reporting group.","id":"EG000","otherNumAffected":41,"otherNumAtRisk":140,"seriousNumAffected":23,"seriousNumAtRisk":140,"title":"All Study Subjects"}],"frequencyThreshold":"4","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":140,"numEvents":11}],"term":"Neutrophil count decrease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":140,"numEvents":6}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":140,"numEvents":14}],"term":"ALT elevation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":140,"numEvents":10}],"term":"AST elevation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":140,"numEvents":9}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":140,"numEvents":9}],"term":"Hearing Loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":140,"numEvents":6}],"term":"Otitis Media"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All Unrelated","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":140,"numEvents":8}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All Unrelated","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All Unrelated","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":140,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Benign vascular lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Eye swelling result of brain mass that has been confirmed as metastatic recurrent neuroblastoma.\n\nUnrelated","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Swelling of Eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Possibly related","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Possibly related","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Respiratory Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Possibly related","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"hearing loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Femur Fracture- Unrelated","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Unrelated","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"gastric obstruction secondary to adhesions from previous surgery. Resolved after surgical correction.\n\nUnrelated","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":140,"numEvents":1}],"term":"Obstruction"}],"timeFrame":"Through study completion plus 30 days, an average of 2 years."}