{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Subjects with Grade 3 abnormality"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Subjects with Grade 4 abnormality"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Subjects with Grade 5 abnormality"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.\n\ngrade 1 : mild\n\ngrade 2 : moderate\n\ngrade 3 : severe or medically significant but not immediately life-threatening\n\ngrade 4 : life threatening or disabling\n\ngrade 5 : death related to AE","groups":[{"description":"SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.","id":"OG000","title":"SyB L-0501 + Prednisolone"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 2 years","title":"Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values","type":"SECONDARY","unitOfMeasure":"Participants"}