{"description":"Adverse events data collected at screening, during clinical visit assessments and at follow-up and off treatment visits.\n\nTwo Serious Adverse Events were Attributed to Study Treatment (2 events in 2 patients; excludes events from other causes):\n\nCARDIAC DISORDERS (Heart failure) EYE DISORDERS (Other)","eventGroups":[{"deathsNumAffected":23,"deathsNumAtRisk":64,"description":"Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before \\& after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days \\& CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed \\& Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \\& Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed \\& Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.","id":"EG000","otherNumAffected":46,"otherNumAtRisk":64,"seriousNumAffected":17,"seriousNumAtRisk":64,"title":"Vaccine + Chemokine Modulatory Regimen"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":64}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":64}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":64}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":64}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":64}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":64}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":64}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":64}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":64}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":64}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":64}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":64}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":64}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":64}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":64}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":64}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":64}],"term":"Chills"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Attributed to Study Treatment","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Attributed to Study Treatment","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Renal and urinary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Colonic obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Not Attributed to Study Treatment","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64}],"term":"Lipase increased"}],"timeFrame":"3 years, 6 months"}