{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33"}]}],"title":"Grade 3 abnormalities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"}]}],"title":"Grade 4 abnormalities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}],"title":"Grade 5 abnormalities"}],"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.","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 Abnormalities (Grade ≥3) in Laboratory Test Values","type":"SECONDARY","unitOfMeasure":"Events"}