{"classes":[{"categories":[{"measurements":[{"comment":"MTD for QOD dosing was not determined as no DLTs were observed for TAS-120 up to 200 mg QOD as the highest dose level studied.","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"20"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"44"}],"units":"Participants"}],"description":"MTD:Highest dose level at which \\<33% of participants experience dose-limiting toxicity (DLT) during Cycle1. DLT: \\>=Grade(G)3: - nonhematologic toxicity, - nausea/vomiting lasting \\>48hrs(uncontrolled by aggressive antiemetic), - diarrhea lasting \\>48hrs (unresponsive to antidiarrheal drug); G4 neutropenia lasting \\>7days; Febrile neutropenia (ANC\\<1000/mm\\^3 with body temperature=\\>38.3°C/sustained temperature \\>=38°C for \\>1hr; Thrombocytopenia G4/G3 with bleeding, required blood transfusion; Corneal disorder worsened by 1 grade or more; Increased phosphorus: \\>=9mg/dL or \\>=7mg/dL lasting for \\>=7days or phosphate lowering therapy\\[PLT\\] for 7days); Creatinine increase (\\>1.5×upper limit of normal \\[ULN\\]) lasting for \\>=7 days associated with serum phosphorus \\>5.5 mg/dL(PLT=7days)/calcium×phosphorus \\>55 mg/dL(PLT=7days); Hypercalcemia G2 for \\>7days or G3; Ectopic de novo calcification in soft tissues; \\>G2 DLT: prevented Cycle 1 completion, inability to start Cycle 2 within 2 weeks of schedule.","groups":[{"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 at 4 DLs from 8 to 36 mg orally every other day (QOD; Monday, Wednesday and Friday of each week) and participants with FGF/FGFR abnormalities received orally TAS-120 at 6 DLs from 56 mg to 240 mg QOD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 11 months).","id":"OG000","title":"Phase 1: Dose Escalation: QOD Dosing"},{"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 4 to 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, or any other discontinuation criterion was met (maximum exposure: 24 months).","id":"OG001","title":"Phase 1: Dose Escalation: QD Dosing"}],"paramType":"NUMBER","populationDescription":"Analysis was performed on DLT evaluable population that included all participants in Phase 1 Dose Escalation who had either experience a DLT during the first cycle of treatment or who had complete the first cycle with at least 80% of planned TAS-120 administered.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (21-day cycle)","title":"Phase 1: Dose Escalation-Maximum Tolerated Dose (MTD)","type":"PRIMARY","unitOfMeasure":"Milligrams"}