TriangleNCT01849848 · OUTCOME
Complete Response (CR) Based on the Blade Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of paticipants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to around 44 weeks
What was measured
The criteria for CR based on the Blade are shown below. CR requires all of the followings: 1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks 2. \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy 3. No increase in size or number of lytic bone lesions 4. Disappearance of soft tissue plasmacytomas
Groups in this outcome
SyB L-0501
SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
| Group | Source count |
|---|---|
| SyB L-0501 | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SyB L-0501 | 0 | Not reported | 0.0 | 19.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 19.5
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 17
- units
- Participants
- description
- The criteria for CR based on the Blade are shown below. CR requires all of the followings: 1. Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks 2. \<5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy 3. No increase in size or number of lytic bone lesions 4. Disappearance of soft tissue plasmacytomas
- dispersion Type
- 95% Confidence Interval
- groups
- description
- SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
- id
- OG000
- title
- SyB L-0501
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- up to around 44 weeks
- title
- Complete Response (CR) Based on the Blade Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of paticipants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice