{"calculatePct":false,"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"12"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"10"}],"title":"Cohort B - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"179"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"12"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"47"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"22"}],"title":"Cohort B - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Missing"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"197"},{"groupId":"OG003","value":"53"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"title":"Hematocrit"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"6"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"13"}],"title":"Cohort B - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"210"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"11"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"43"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"18"}],"title":"Cohort B - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"1"}],"title":"Cohort B - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Missing"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"35"},{"groupId":"OG002","value":"218"},{"groupId":"OG003","value":"50"},{"groupId":"OG004","value":"2"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"title":"Hemoglobin"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"3"}],"title":"Cohort B - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"230"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"13"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"70"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"29"}],"title":"Cohort B - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Missing"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"237"},{"groupId":"OG003","value":"72"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"title":"Platelets"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"36"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"10"}],"title":"Cohort B - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"194"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"11"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"39"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"22"}],"title":"Cohort B - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Missing"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"205"},{"groupId":"OG003","value":"42"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"title":"Erythrocytes"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"2"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"2"}],"title":"Cohort B - Baseline Value: Low"},{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"208"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"18"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"12"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"71"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"30"}],"title":"Cohort B - Baseline Value: Normal"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"2"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: High"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort A - Baseline Value: Missing"},{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}],"title":"Cohort B - Baseline Value: Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"220"},{"groupId":"OG003","value":"75"},{"groupId":"OG004","value":"23"},{"groupId":"OG005","value":"3"},{"groupId":"OG006","value":"14"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"title":"Leukocytes"}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"117"},{"groupId":"OG002","value":"268"},{"groupId":"OG003","value":"117"},{"groupId":"OG004","value":"268"},{"groupId":"OG005","value":"117"},{"groupId":"OG006","value":"268"},{"groupId":"OG007","value":"117"}],"units":"Participants"}],"description":"Shifts from baseline to worst post-baseline visit for hematology laboratory values for all participants included in the Safety Set. The Safety Set includes all participants who received any amount of 18F-DCFPyL. Data are presented for participants in Cohort A and Cohort B.","groups":[{"description":"Cohort A participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.","id":"OG000","title":"Cohort A - Follow-up Value: Low"},{"description":"Cohort B participants who had a follow-up laboratory value that was below the lower limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.","id":"OG001","title":"Cohort B - Follow-up Value: Low"},{"description":"Cohort A participants who had a follow-up laboratory value that was within normal limit. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.","id":"OG002","title":"Cohort A - Follow-up Value: Normal"},{"description":"Cohort B participants who had a follow-up laboratory value that was within normal limits. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.","id":"OG003","title":"Cohort B - Follow-up Value Normal"},{"description":"Cohort A participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.","id":"OG004","title":"Cohort A - Follow-up Value: High"},{"description":"Cohort B participants who had a follow-up laboratory value that was above the upper limit of normal. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.","id":"OG005","title":"Cohort B - Follow-up Value: High"},{"description":"Cohort A participants who did not have a follow-up laboratory value. Cohort A were high risk cancer participants planned for radical prostatectomy with pelvic lymph node dissection.","id":"OG006","title":"Cohort A - Follow-up Value: Missing"},{"description":"Cohort B participants who did not have a follow-up laboratory value. Cohort B were participants with presumptive radiologic evidence of prostate cancer recurrence or metastasis on conventional imaging and planned for conventional image-guided biopsy.","id":"OG007","title":"Cohort B - Follow-up Value: Missing"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The Safety Set includes all participants who received any amount of 18F-DCFPyL.","reportingStatus":"POSTED","timeFrame":"From time of screening (baseline) until pre-surgery/biopsy (within 28 days post-study drug dosing).","title":"Shift From Baseline in Selected Hematology Laboratory Values at Follow-up (Safety Outcome Measure)","type":"SECONDARY","unitOfMeasure":"Participants"}