TriangleNCT00153920 · OUTCOME
Very Good Partial Response (VGPR) Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
What was measured
Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a \>90% decrease in the difference between involved and uninvolved FLC levels.
Analysis population: The analysis population is comprised of eligible and treated participants.
Groups in this outcome
Bortezomib
Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
| Group | Source count |
|---|---|
| Bortezomib | 64 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib | .17 | Not reported | .089 | .287 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- .089
- upper Limit
- .287
- value
- .17
- denoms
- counts
- group Id
- OG000
- value
- 64
- units
- Participants
- description
- Very good partial response or better was defined per International Uniform Response criteria (Durie B, Harousseau JL, Miquel JS, et al Leukemia 2006). See CR requirements in primary outcome measure plus if serum and urine M protein were unmeasurable then immunoglobulin free light chain (FLC) must be in a normal ratio of 0.26-1.65 at two consecutive times. VGPR required the following: Serum and urine M-component detectable by immunofixation but not on electrophoresis; \>=90% reduction in serum M-component plus urine M-component \<100 mg per 24 hours (by SPEP and UPEP); if the serum and urine M protein were unmeasurable then a \>90% decrease in the difference between involved and uninvolved FLC levels.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
- id
- OG000
- title
- Bortezomib
- param Type
- NUMBER
- population Description
- The analysis population is comprised of eligible and treated participants.
- reporting Status
- POSTED
- time Frame
- Response was assessed every two cycles on treatment. Treatment duration in months was a median (range) of 5.1 (0.8-6.1).
- title
- Very Good Partial Response (VGPR) Rate
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice