{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"241"}]}],"title":"TEAE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"79"}]}],"title":"TESAE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"246"}],"units":"Participants"}],"description":"An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs.","groups":[{"description":"Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.","id":"OG000","title":"Trifluridine/Tipiracil + Bevacizumab"},{"description":"Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.","id":"OG001","title":"Trifluridine/Tipiracil"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Analysis was performed on safety set which included all participants who had taken at least one dose of investigational medicinal products and were analyzed according to the treatment they actually received.","reportingStatus":"POSTED","timeFrame":"From baseline (Cycle 1 Day 1) up to 30 days after the last dose of study drug (i.e., up to 30.7 months)","title":"Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs)","type":"SECONDARY","unitOfMeasure":"Participants"}