{"classes":[{"categories":[{"measurements":[{"comment":"Mean and standard deviation (SD) cannot be reported as the value was below quantification limit (BQL) (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 0 (predose)"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 3"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 6"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 9"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 15"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 18"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"Gemcitabine: Week 21"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 0 (predose)"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 3"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 6"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 9"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 15"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 18"},{"categories":[{"measurements":[{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Mean and SD cannot be reported as the value was BQL (\\<0.100 mcg/mL).","groupId":"OG001","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"title":"dFdU: Week 21"}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"0"}],"units":"Participants"}],"description":"Plasma concentrations of gemcitabine and dFdU were reported.","dispersionType":"Standard Deviation","groups":[{"description":"Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).","id":"OG000","title":"Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)"},{"description":"Participants with CIS with or without papillary disease, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.","id":"OG001","title":"Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)"},{"description":"Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.","id":"OG002","title":"Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)"}],"paramType":"MEAN","populationDescription":"FAS was analyzed. Here \"N\" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM), \"n\" (number analyzed) signifies number of participants evaluable at specific timepoints. N=0 because data was not collected or analyzed, as urine was the major pharmacokinetic matrix; therefore, plasma Gemcitabine and dFdU concentrations were not assessed in the Cohort 4. This OM was planned to be analyzed for Cohorts 1, 2, and 4 only.","reportingStatus":"POSTED","timeFrame":"Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdose","title":"Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)","type":"SECONDARY","unitOfMeasure":"microgram per milliliter (mcg/mL)"}