{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.3"},{"groupId":"OG001","value":"93.2"}]}],"title":"Any adverse event (AE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"85.7"},{"groupId":"OG001","value":"54.7"}]}],"title":"Any treatment-related AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"69.4"},{"groupId":"OG001","value":"51.7"}]}],"title":"Any ≥Grade 3 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"49.0"},{"groupId":"OG001","value":"9.8"}]}],"title":"Any treatment-related ≥Grade 3 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29.6"},{"groupId":"OG001","value":"33.6"}]}],"title":"Any serious AE (SAE)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10.3"},{"groupId":"OG001","value":"13.6"}]}],"title":"Any AE resulting in discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3.2"},{"groupId":"OG001","value":"11.3"}]}],"title":"Any AE with outcome of death"}],"denoms":[{"counts":[{"groupId":"OG000","value":"533"},{"groupId":"OG001","value":"265"}],"units":"Participants"}],"description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AEs were events between administration of study drug and up to 30 Days that were absent before treatment or that worsened relative to pre-treatment state. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability /incapacity; congenital anomaly. The AEs were graded for severity using National Cancer Institute Common Terminology Criteria for AEs.","groups":[{"description":"Participants received TAS-102 orally with a starting dose of 35 mg/m\\^2/dose BID based on BSA along with BSC. The first dose of TAS-102 was administered in the morning of Day 1 of each cycle and the last dose was administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle = 28 days). Participants received study medication until any of the discontinuation criteria were met.","id":"OG000","title":"TAS-102"},{"description":"Participants orally received TAS-102 matching placebo BID dose along with BSC with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5, followed by rest on Day 6 and 7, treatment was repeated for next week starting from Day 8 to Day 12, followed by a 16-day rest starting from Day 13 to Day 28 (1 treatment cycle). Participants received study medication until any of the discontinuation criteria.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Safety analysis was performed on as treated (AT) population including all participants who took part of any dose of the study medication.","reportingStatus":"POSTED","timeFrame":"From the time of signing the informed consent form until the period of participant follow up (30 days following after the administration of last dose of study medication or until initiation of new antitumor therapy, whichever was earlier","title":"Percentage of Participants With Adverse Events (AE), Treatment-Related AEs, Discontinuations, Serious Adverse Events (SAEs) and Deaths","type":"SECONDARY","unitOfMeasure":"percentage of participants"}