{"eventGroups":[{"description":"Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":16,"otherNumAtRisk":18,"seriousNumAffected":8,"seriousNumAtRisk":18,"title":"MDX-010"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":7}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":3}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18,"numEvents":11}],"term":"Diarrhea-No Colostom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Lip pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Oral cavity Mucositis/stomatitis (functional/symptomatic)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18,"numEvents":9}],"term":"Pain-Abdominal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pain-Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Edema: Limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":18,"numEvents":22}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Fever-No ANC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":3}],"term":"Rigors"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Alkaline phosphatase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Creatinine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":4}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18,"numEvents":9}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":6}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Glucose intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":5}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":4}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hypermatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":3}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18,"numEvents":6}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":3}],"term":"Impotence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":5}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":2}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pulmonary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Rhinitis Allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":6}],"term":"Rash/Desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Sweating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Hot flashes"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Diarrhea-No Colostom"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Blood gonadotrophin abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Facial nerve disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 6","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pneumonitis"}]}