{"eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":3,"description":"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.\n\nPatients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients).","id":"EG000","otherNumAffected":2,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase I: Dose Escalation 1-5 mCi in 50mg of Antibody"},{"deathsNumAffected":2,"deathsNumAtRisk":7,"description":"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.\n\nPatients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients).","id":"EG001","otherNumAffected":5,"otherNumAtRisk":7,"seriousNumAffected":0,"seriousNumAtRisk":7,"title":"Phase I: Dose Escalation 1-5 mCi in 20mg of Antibody"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Three patients will be administered 2 mCi of 89Zr-daratumumab in a total of 50 mg of daratumumab antibody. Administered activity (1 to 5 mCi) of radioactivity and total amount of administered antibody (3 to 50 mg) will be adjusted in subsequent patients in order to maximize image quality.\n\nPatients in phase I will have up to 4 PET/CT scans, multiple blood draws, whole-body counts, and safety monitoring to determine pharmacokinetics, radiation dosimetry, and safety of 89Zr-DFO-daratumumab for PET/CT imaging. Phase II (total of 21-24 patients).","id":"EG002","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Phase I: Dose Escalation 1-5 mCi in 3-50mg of Antibody"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":4,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Platelet count decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":7},{"groupId":"EG002","numAffected":0,"numAtRisk":1}],"term":"Sinus tachycardia"}],"timeFrame":"approximately 1 year 7 months"}