{"description":"The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":22,"description":"Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of \"KLH only\" vaccine.\n\nCD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously","id":"EG000","otherNumAffected":20,"otherNumAtRisk":22,"seriousNumAffected":6,"seriousNumAtRisk":22,"title":"Arm A"},{"deathsNumAffected":0,"deathsNumAtRisk":18,"description":"Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)\n\nCD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously","id":"EG001","otherNumAffected":16,"otherNumAtRisk":18,"seriousNumAffected":4,"seriousNumAtRisk":18,"title":"Arm B"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":22},{"groupId":"EG001","numAffected":7,"numAtRisk":18}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":22},{"groupId":"EG001","numAffected":12,"numAtRisk":18}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":22},{"groupId":"EG001","numAffected":10,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":22},{"groupId":"EG001","numAffected":6,"numAtRisk":18}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"General disorders and administration site conditions - Other (Achiness at injection site)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"General disorders and administration site conditions - Other (Body aches)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NIH CTC, version 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4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Infections and infestations - Other (C.Diff)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":22},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 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decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":18}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":22},{"groupId":"EG001","numAffected":4,"numAtRisk":18}],"term":"Papulopustular rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NIH CTC, version 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connective tissue disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":18}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NIH CTC, version 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syndrome)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NIH CTC, version 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":18}],"term":"Vomiting"}],"timeFrame":"1 year"}