{"description":"AEs were coded using MedDRA and data listed by patient, including study site, patient identifier, age, race, AE (MedDRA SOC, PT and verbatim term), dates of onset and resolution, duration, CTCAE toxicity grade, seriousness, action taken, outcome and causality. Deaths, SAEs and AEs leading to discontinuation were also listed by patient","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":356,"description":"All patients who received the rhPSMA-7.3 (18F) injection. The FSP was used for all safety summaries.","id":"EG000","otherNumAffected":28,"otherNumAtRisk":356,"seriousNumAffected":0,"seriousNumAtRisk":356,"title":"Full Safety Population (FSP)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Tracheal deviation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Aortic aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":356,"numEvents":2}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Thrombophlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":356,"numEvents":5}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":3}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":356,"numEvents":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Nervousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Haematuria traumatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Lower urinary tract symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Spinal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":356,"numEvents":1}],"term":"Hyperkalaemia"}],"timeFrame":"All AEs were recorded throughout the study from informed consent through study completion, an average of 60 days post-IMP administration."}