{"description":"A serious adverse event (SAE) is any AE that: results in death, is immediately life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in offspring of the subject, is an important medical event that may jeopardize the subject or may require medical intervention to prevent one of the outcomes listed above.","eventGroups":[{"deathsNumAffected":11,"deathsNumAtRisk":19,"description":"Subjects will receive durvalumab and tremelimumab both via intravenous infusion once per day for every 28 day cycles (+ 7 days). Participants will receive tremelimumab for up to 4 cycles (4 doses). Beginning with cycle 5 day 1, subjects will continue to receive durvalumab alone, until clinical or radiological progression.\n\nTremelimumab: Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.\n\nDurvalumab: Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.","id":"EG000","otherNumAffected":19,"otherNumAtRisk":19,"seriousNumAffected":4,"seriousNumAtRisk":19,"title":"Tremelimumab + Durvalumab"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Congenital, familial and genetic disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Vertigo"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":19,"numEvents":7}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Rash pustular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Serum amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":19,"numEvents":6}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Metabolism and nutrition disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Tumor pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hoarseness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Laryngeal mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":19,"numEvents":3}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":19,"numEvents":4}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Aspartate aminotransferase increased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":19,"numEvents":2}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Spinal Cord Compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.03)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":19,"numEvents":1}],"term":"Adult respiratory distress syndrome"}],"timeFrame":"Adverse events were collected from time of first dose through end of follow-up, every 3 weeks during active therapy. The median of the observation period for all-cause mortality is 27.33 months with range (0.76 months - 50.40 months). The median of observation time for AE is 1.91 months with range (0.00 months - 23.46 months)."}