{"description":"AEs (treatment emergent) were coded with MedDRA and data listed by patient: 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 listed by patient","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":391,"description":"Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan\n\nrhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning\n\nPositron emission tomography scan: Imaging scan with radioligand","id":"EG000","otherNumAffected":28,"otherNumAtRisk":391,"seriousNumAffected":2,"seriousNumAtRisk":391,"title":"Single Arm"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":391,"numEvents":7}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":391,"numEvents":2}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Injection site discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":391,"numEvents":2}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":391,"numEvents":4}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Ureterolithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Hypoglycaemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 23","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":391,"numEvents":1}],"term":"Pulmonary embolism"}],"timeFrame":"AEs were also monitored throughout the study through study completion, an average of 90 days post-IMP administration."}