{"description":"Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.","eventGroups":[{"description":"GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.","id":"EG000","otherNumAffected":112,"otherNumAtRisk":127,"seriousNumAffected":17,"seriousNumAtRisk":127,"title":"GM-CSF"},{"description":"Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.","id":"EG001","otherNumAffected":282,"otherNumAtRisk":292,"seriousNumAffected":75,"seriousNumAtRisk":292,"title":"Talimogene Laherparepvec"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":127},{"groupId":"EG001","numAffected":15,"numAtRisk":292}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":127},{"groupId":"EG001","numAffected":26,"numAtRisk":292}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":34,"numAtRisk":292}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":127},{"groupId":"EG001","numAffected":55,"numAtRisk":292}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":15,"numAtRisk":292}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":127},{"groupId":"EG001","numAffected":104,"numAtRisk":292}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":127},{"groupId":"EG001","numAffected":61,"numAtRisk":292}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":127},{"groupId":"EG001","numAffected":141,"numAtRisk":292}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":127},{"groupId":"EG001","numAffected":147,"numAtRisk":292}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":127},{"groupId":"EG001","numAffected":88,"numAtRisk":292}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":127},{"groupId":"EG001","numAffected":15,"numAtRisk":292}],"term":"Injection site erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":81,"numAtRisk":292}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":127},{"groupId":"EG001","numAffected":5,"numAtRisk":292}],"term":"Injection site pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":127},{"groupId":"EG001","numAffected":9,"numAtRisk":292}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":10,"numAtRisk":292}],"term":"Injection site swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":127},{"groupId":"EG001","numAffected":34,"numAtRisk":292}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":127},{"groupId":"EG001","numAffected":47,"numAtRisk":292}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":127},{"groupId":"EG001","numAffected":121,"numAtRisk":292}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":29,"numAtRisk":292}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":17,"numAtRisk":292}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":127},{"groupId":"EG001","numAffected":30,"numAtRisk":292}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":127},{"groupId":"EG001","numAffected":50,"numAtRisk":292}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":127},{"groupId":"EG001","numAffected":27,"numAtRisk":292}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127},{"groupId":"EG001","numAffected":13,"numAtRisk":292}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127},{"groupId":"EG001","numAffected":14,"numAtRisk":292}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127},{"groupId":"EG001","numAffected":51,"numAtRisk":292}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127},{"groupId":"EG001","numAffected":14,"numAtRisk":292}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":127},{"groupId":"EG001","numAffected":48,"numAtRisk":292}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":127},{"groupId":"EG001","numAffected":19,"numAtRisk":292}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":127},{"groupId":"EG001","numAffected":28,"numAtRisk":292}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":127},{"groupId":"EG001","numAffected":55,"numAtRisk":292}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":127},{"groupId":"EG001","numAffected":19,"numAtRisk":292}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":127},{"groupId":"EG001","numAffected":15,"numAtRisk":292}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":127},{"groupId":"EG001","numAffected":21,"numAtRisk":292}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":127},{"groupId":"EG001","numAffected":31,"numAtRisk":292}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":127},{"groupId":"EG001","numAffected":13,"numAtRisk":292}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":17,"numAtRisk":292}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":127},{"groupId":"EG001","numAffected":21,"numAtRisk":292}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":127},{"groupId":"EG001","numAffected":23,"numAtRisk":292}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":127},{"groupId":"EG001","numAffected":28,"numAtRisk":292}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":127},{"groupId":"EG001","numAffected":26,"numAtRisk":292}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":15,"numAtRisk":292}],"term":"Vitiligo"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Angina pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Cardiac failure congestive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Intussusception"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Small intestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":127},{"groupId":"EG001","numAffected":9,"numAtRisk":292}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":5,"numAtRisk":292}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":7,"numAtRisk":292}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Parotitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Pelvic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Anaemia postoperative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Delayed recovery from anaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Foot fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Pelvic fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Radiation associated pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Rib fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Seroma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Wound decomposition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Diabetic ketoacidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Bursitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Spinal column stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Bladder transitional cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Infected neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Melanoma recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Metastatic malignant melanoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Plasmacytoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":4,"numAtRisk":292}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Central nervous system lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Convulsion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Pneumocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Transient ischaemic attack"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Glomerulonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Nephrolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Renal papillary necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Bronchial hyperreactivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Obstructive airways disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Pleuritic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":2,"numAtRisk":292}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":127},{"groupId":"EG001","numAffected":0,"numAtRisk":292}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":3,"numAtRisk":292}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 15.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":127},{"groupId":"EG001","numAffected":1,"numAtRisk":292}],"term":"Venous thrombosis limb"}],"timeFrame":"From first dose of study drug until 30 days after the last dose; Median duration of treatment was 10 weeks (range 0.6 to 72 weeks) in GM-CSF group and 23 weeks (range 0.1 to 78.9 weeks) in the talimogene laherparepvec group."}