{"description":"Safety Population (all treated participants) included all participants who had received at least 1 dose of TAS-120. MedDRA version 17.0 for Phase 1 and MedDRA version 22.0 for Phase 2. Safety analysis were done based on data cut-off dates: 12 July 2019 for Phase 1 Dose Escalation, 29-May-2021 for Phase 1 Dose Expansion and Phase 2.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 8 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Phase 1: Dose Escalation: QOD Dosing: 8 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 16 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Phase 1: Dose Escalation: QOD Dosing: 16 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 24 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG002","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1: Dose Escalation: QOD Dosing: 24 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants with or without FGF/FGFR gene abnormalities received orally TAS-120 36 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1: Dose Escalation: QOD Dosing: 36 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 56 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG004","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"Phase 1: Dose Escalation: QOD Dosing: 56 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 80 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG005","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Phase 1: Dose Escalation: QOD Dosing: 80 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 120 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG006","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":4,"seriousNumAtRisk":4,"title":"Phase 1: Dose Escalation: QOD Dosing: 120 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":8,"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 160 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG007","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":7,"seriousNumAtRisk":8,"title":"Phase 1: Dose Escalation: QOD Dosing: 160 mg"},{"deathsNumAffected":2,"deathsNumAtRisk":7,"description":"Participants with FGF/FGFR gene abnormalities received orally TAS-120 200 mg orally QOD (Monday, Wednesday and Friday of each week) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG008","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":4,"seriousNumAtRisk":7,"title":"Phase 1: Dose Escalation: QOD Dosing: 200 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 4 mg orally once daily (QD) in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG009","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Phase 1: Dose Escalation: QD Dosing: 4 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 8 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG010","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":1,"seriousNumAtRisk":5,"title":"Phase 1: Dose Escalation: QD Dosing: 8 mg"},{"deathsNumAffected":2,"deathsNumAtRisk":14,"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 16 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG011","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":9,"seriousNumAtRisk":14,"title":"Phase 1: Dose Escalation: QD Dosing: 16 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":7,"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 20 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG012","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"Phase 1: Dose Escalation: QD Dosing: 20 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":14,"description":"Participants with or without FGF/FGFR gene abnormalities received a dose between 24 mg orally QD in a 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.","id":"EG013","otherNumAffected":14,"otherNumAtRisk":14,"seriousNumAffected":6,"seriousNumAtRisk":14,"title":"Phase 1: Dose Escalation: QD Dosing: 24 mg"},{"deathsNumAffected":40,"deathsNumAtRisk":57,"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 (maximum exposure: 33.5 months).","id":"EG014","otherNumAffected":57,"otherNumAtRisk":57,"seriousNumAffected":27,"seriousNumAtRisk":57,"title":"Phase 1: Dose Expansion Cohort 1"},{"deathsNumAffected":22,"deathsNumAtRisk":34,"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 (maximum exposure: 28.5 months).","id":"EG015","otherNumAffected":34,"otherNumAtRisk":34,"seriousNumAffected":13,"seriousNumAtRisk":34,"title":"Phase 1: Dose Expansion: Cohort 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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 (maximum exposure: 45.5 months).","id":"EG020","otherNumAffected":8,"otherNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"title":"Phase 1: Dose Expansion: Sub-cohort 2"},{"deathsNumAffected":9,"deathsNumAtRisk":19,"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 (maximum exposure: 28 months).","id":"EG021","otherNumAffected":19,"otherNumAtRisk":19,"seriousNumAffected":0,"seriousNumAtRisk":19,"title":"Phase 1: Dose Expansion: Sub-cohort 1"},{"deathsNumAffected":58,"deathsNumAtRisk":103,"description":"Participants with iCCA with tumors harboring 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