TriangleNCT01179490 · OUTCOME
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 36 weeks
What was measured
The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
Groups in this outcome
SyB L-0501 + Prednisolone
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.
| Group | Source count |
|---|---|
| SyB L-0501 + Prednisolone | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 + Prednisolone | 40.0 | Not reported | 5.3 | 85.3 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.3
- upper Limit
- 85.3
- value
- 40.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- units
- Participants
- description
- The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
- dispersion Type
- 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
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Up to 36 weeks
- title
- Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice