{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":268,"description":"Patients with high risk prostate cancer planned for radical prostatectomy with pelvic lymph node dissection were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.","id":"EG000","otherNumAffected":26,"otherNumAtRisk":268,"seriousNumAffected":1,"seriousNumAtRisk":268,"title":"High Risk Prostate Cancer (Cohort A)"},{"deathsNumAffected":0,"deathsNumAtRisk":117,"description":"Patients with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy were enrolled to receive a single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL, followed by PET/CT imaging acquired 1-2 hours post-PyL injection.","id":"EG001","otherNumAffected":1,"otherNumAtRisk":117,"seriousNumAffected":6,"seriousNumAtRisk":117,"title":"Recurrent or Metastatic Prostate Cancer (Cohort B)"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":268},{"groupId":"EG001","numAffected":0,"numAtRisk":117}],"term":"headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":268},{"groupId":"EG001","numAffected":0,"numAtRisk":117}],"term":"fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":268},{"groupId":"EG001","numAffected":0,"numAtRisk":117}],"term":"diarrhea"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"coronary artery disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"Lower gastrointestinal haemmorhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"pyelonephritis, acute"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":268},{"groupId":"EG001","numAffected":1,"numAtRisk":117}],"term":"spinal cord compression"}],"timeFrame":"Treatment-emergent adverse events (TEAEs) were collected from Day 1 after 18F-DCFPyL administration through the day prior to prostatectomy, lymphadenectomy or a change in planned protocol procedure (Cohort A); if a participant did not have a procedure, TEAEs were collected for up to 10 days after 18F-DCFPyL administration. For participants in Cohort B, TEAEs were collected from Day 1 after 18F-DCFPyL administration through 28 days after biopsy."}