{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.3","upperLimit":"85.3","value":"40.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"}],"units":"Participants"}],"description":"The proportion of subjects evaluated as CR was calculated.\n\nCR (modified SWOG) requires all of the followings:\n\n1. Decline in serum myeloma protein by ≥75% to ≤25 g/L\n2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h\n3. No increase in skeletal destruction\n4. Serum calcium within normal range\n5. No blood transfusion required in the previous 3 months","dispersionType":"95% Confidence Interval","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 36 weeks","title":"Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]","type":"PRIMARY","unitOfMeasure":"Percentage of Participants"}