{"classes":[{"categories":[{"measurements":[{"comment":"Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive AUC using NCA method.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Here, NA signifies that data could not be analyzed as due to sparse PK sampling, the data were insufficient to derive AUC using NCA method.","groupId":"OG001","spread":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"},{"groupId":"OG001","value":"149"}],"units":"Participants"}],"description":"Area under the plasma concentration time-curve from time zero to the time t (AUC\\[0-t\\]) was reported.","dispersionType":"Standard Deviation","groups":[{"description":"Participants with advanced urothelial cancer and selected fibroblast growth factor receptor (FGFR) aberrations who were previously treated with anti-programmed death-ligand 1 (PD-\\[L\\]1) agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"OG000","title":"Cohort 1: Arm 1A: Erdafitinib 8 mg/9 mg"},{"description":"Participants with advanced urothelial cancer and selected FGFR aberrations who were not previously treated with anti-PD-(L)1 agent were randomized to receive erdafitinib tablet orally once daily starting from Day 1 through Day 21 in each subsequent 21-day cycles starting from Cycle 1 until disease progression, intolerable toxicity, withdrawal of consent, decision by the investigator to discontinue treatment or end of treatment. All subjects randomized to erdafitinib received erdafitinib 8 mg once daily from Day 1 to Day 14 of Cycle 1. On Day 14 of Cycle 1, serum phosphate concentration was measured. Based on the measured serum phosphate levels the treatment could be up-titrated to erdafitinib 9 mg. With the implementation of Protocol Amendment 6 (20 January 2023), participants who benefited from the study drug as determined by investigator, continued to receive study drug in the LTE phase. The participants who did not enter LTE phase discontinued the study.","id":"OG001","title":"Cohort 2: Arm 2A: Erdafitinib 8 mg/ 9 mg"}],"paramType":"MEAN","populationDescription":"Pharmacokinetic-evaluable analysis set included all randomized participants who received at least 1 dose of erdafitinib and had at least 1 evaluable pharmacokinetic sample obtained posttreatment. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Day 14 of Cycle 1, Day 1 of Cycle 2: pre-dose and 2-4 hours post-dose (each cycle is of 21 days)","title":"Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) of Erdafitinib","type":"SECONDARY","unitOfMeasure":"Nanogram hour per milliliter"}