{"description":"Post-ablation syndrome (PAS) is a common, self-limited adverse event (AE) after thermal ablation, marked by transient fever, fatigue, leukocytosis, and flu-like symptoms within 24-72 h, resolving in 7-10 days. AEs related to PAS were recorded as per CTCAE v5.0 within 30 days of ablation and not specifically labeled as PAS.","eventGroups":[{"deathsNumAffected":26,"deathsNumAtRisk":74,"description":"Clinical impact of Morfeus software usage on patients undergoing percutaneous ablation of liver tumors","id":"EG000","otherNumAffected":18,"otherNumAtRisk":74,"seriousNumAffected":39,"seriousNumAtRisk":74,"title":"Experimental"},{"deathsNumAffected":6,"deathsNumAtRisk":26,"description":"Morfeus software was not used during the percutaneous ablation of liver tumors","id":"EG001","otherNumAffected":3,"otherNumAtRisk":26,"seriousNumAffected":12,"seriousNumAtRisk":26,"title":"Control"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74,"numEvents":12},{"groupId":"EG001","numAffected":2,"numAtRisk":26,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Infection (COVID-19)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Hematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":74,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Memory impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Hematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Rectal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Shoulder pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":74,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":26,"numEvents":4}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":74,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":74,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Allergic reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Colonic obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Breast infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Bleeding"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":74,"numEvents":26},{"groupId":"EG001","numAffected":6,"numAtRisk":26,"numEvents":6}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":74,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":74,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Heart failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Encephalopathy (liver)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Hepatic failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Pain (hip)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Infection (suspected cholangitis)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Ischemia (vascular disorder)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":74,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":26,"numEvents":1}],"term":"Portal vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Bleeding (vaginal)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Infection (Urinary Tract)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Pneumothorax"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (5.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74},{"groupId":"EG001","numAffected":0,"numAtRisk":26,"numEvents":0}],"term":"Creatinine increased"}],"timeFrame":"Enrollment to 2-year follow-up, lost of follow-up, or death, whichever occurred first. AEs were classified as related (within 30 days) and unrelated to the thermal ablation procedure."}