{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"103"}]}],"title":"AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"}]}],"title":"SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"103"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical condition that occurs 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 iCCA with tumors harboring FGFR2 gene rearrangements 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 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 37.5 months (through cut-off date 29-May-2021)","title":"Phase 2: Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}