{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"23"},{"groupId":"OG005","value":"26"},{"groupId":"OG006","value":"18"},{"groupId":"OG007","value":"5"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"13"},{"groupId":"OG005","value":"14"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"13"},{"groupId":"OG004","value":"24"},{"groupId":"OG005","value":"27"},{"groupId":"OG006","value":"19"},{"groupId":"OG007","value":"8"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical condition that occurred in a participant from the time the informed consent form (ICF) was signed and does not necessarily had a causal relationship with the use of the product. An SAE was an AE that falls into one or more of the following categories: a. resulted in death, b. was life threatening, c. required inpatient hospitalization or prolongation of existing hospitalization, d. resulted in persistent or significant disability or incapacity, e. was a congenital anomaly/birth defect, f. other important medical event.","groups":[{"description":"Participants with intra-hepatic or extrahepatic cholangiocarcinoma (iCCA or eCCA) harboring FGFR2 gene fusions or rearrangements and who were treated or not treated with prior FGFR inhibitors received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG000","title":"Phase 1: Dose Expansion Cohort 1"},{"description":"Participants with primary central nervous system (CNS) tumors harboring FGFR gene fusions or FGFR1 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG001","title":"Phase 1: Dose Expansion: Cohort 2"},{"description":"Participants with advanced urothelial carcinoma harboring FGFR3 gene fusions or FGFR3 activating mutations received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG002","title":"Phase 1: Dose Expansion: Cohort 3"},{"description":"Participants with breast or gastric cancer with harboring FGFR2 amplification received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG003","title":"Phase 1: Dose Expansion: Cohort 4"},{"description":"Participants with tumor types harboring FGFR gene fusions or activating mutations received TAS-120 20 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG004","title":"Phase 1: Dose Expansion: Cohort 5"},{"description":"Participants who were not included in Cohorts 1 to 5 received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG005","title":"Phase 1: Dose Expansion: Cohort 6"},{"description":"Participants with iCCA who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21- day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG006","title":"Phase 1: Dose Expansion: Sub-cohort 1"},{"description":"Participants with other tumor types who were enrolled prior to the confirmation of the RP2D received TAS-120 16 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"OG007","title":"Phase 1: Dose Expansion: Sub-cohort 2"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120.","reportingStatus":"POSTED","timeFrame":"From the first dose up to approximately 50.5 months (through cut-off date 29-May-2021)","title":"Phase 1: Dose Expansion: Number of Participants With Any Adverse Events (AEs) and Any Serious AEs (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}