{"description":"Adverse events were reported and coded using the Modified NCI Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.0","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":10,"description":"Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT\n\nGemcitabine: Gemcitabine will be administered on days 1, 8, 15 every 28 days\n\nTT vaccine booster: One human TT childhood vaccine booster will be administered on day 8","id":"EG000","otherNumAffected":10,"otherNumAtRisk":10,"seriousNumAffected":2,"seriousNumAtRisk":10,"title":"Gemcitabine With TT Vaccine Booster"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Rash maculo-papular"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Abdominal Pain, Intermittent Abdominal Pain, Abdominal Discomfort","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":10}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Dyspnea, Shortness of Breath","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Chest Pain, Occasional Chest Pain","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Chest Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Bilateral Lower Extremity Edema","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Edema Limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Weakness","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":10}],"term":"Generalized Muscle Weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Intermittent Cough, Blood-tinged Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Poor Appetite, Poor PO Intake, Appetite Change","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":10}],"term":"Poor Appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Weight Loss, Weight Loss (\\>40lbs in one month)","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":10}],"term":"Weight Loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Gait Problem","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Gait Disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Neutropenic","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Febrile Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Emesis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Thrombocytopenia","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Spleen Disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10}],"term":"Back Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Glucose, uncontrolled","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Numbness of Hands, Numbness in Extremities","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Sleep Disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Hearing Loss","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Hearing Impaired"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Arthralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Burping","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Bloating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Left Upper Extremity (LUE) Pain; Left Lateral Thigh Pain","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Pain in Extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Left Upper Quadrant (LUQ) Pain; Right Upper Quadrant (RUQ) Pain","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10}],"term":"Pain (general)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Blood in Stool"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Terms: Deep Vein Thrombosis (DVT) in Right Lower Extremity; Superficial Vein Thrombosis","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10}],"term":"Thromboembolic Event"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Verbatim Term: Perforated Gall Bladder","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Gallbladder Perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10,"numEvents":1}],"term":"Duodenal Hemorrhage"}],"timeFrame":"Up to 1 month following Gemcitabine administration, for a total of up to 2 months"}