TriangleNCT00675428 · OUTCOME
Number Of Participants Who Achieve A Complete Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Day 1 up to Month 6
What was measured
Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of \> 4:1 or \< 1:2 performed on a minimum of 100 plasma cells.
Groups in this outcome
Natalizumab 300 mg
Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
Natalizumab 450 mg
Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
| Group | Source count |
|---|---|
| Natalizumab 300 mg | 3 |
| Natalizumab 450 mg | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Natalizumab 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Natalizumab 450 mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Response rates were classified according to the International Uniform Response Criteria for Multiple Myeloma (Durie et al, 2006). Complete Response (CR): negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas , and ≤ 5% plasma cells in the bone marrow. Stringent CR (sCR): CR as defined above, and normal free light chain (FLC) ratio, and absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence, based on a κ/λ ratio of \> 4:1 or \< 1:2 performed on a minimum of 100 plasma cells.
- groups
- description
- Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
- id
- OG000
- title
- Natalizumab 300 mg
- description
- Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
- id
- OG001
- title
- Natalizumab 450 mg
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Day 1 up to Month 6
- title
- Number Of Participants Who Achieve A Complete Response
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice