{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":208,"description":"Participants with suspected recurrence of prostate cancer and negative or equivocal findings per institutional standard of care conventional imaging were enrolled to receive a single dose of 9 mCi (333 MBq) 18F-DCFPyL injection followed by a single PET/CT scan acquired 1 to 2 hours post-dosing.","id":"EG000","otherNumAffected":7,"otherNumAtRisk":208,"seriousNumAffected":1,"seriousNumAtRisk":208,"title":"18F-DCFPyL Injection"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":208}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":208}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":208}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":208}],"term":"Hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":208}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":208}],"term":"Paresthesia"}],"timeFrame":"Treatment-emergent adverse events were collected after 18F-DCFPyL administration on Day 1 post-dose through the safety visit 7 (±3) days post-dosing."}