{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Subjects with adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"}]}],"title":"Subjects with related adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Subjects with serious adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Subjects with related serious adverse event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02, Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).","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 Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event","type":"SECONDARY","unitOfMeasure":"Participants"}