TriangleNCT00843882 · OUTCOME
Proportion of Patients With Cytogenetic Response
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
- Assessed at baseline and after completion of 16 weeks of treatment
What was measured
Evaluation of cytogenetic response requires 20 analyzable metaphases when using conventional techniques. Analysis of data will require 20 metaphases before and after treatment, which must be done on bone marrow only (peripheral blood is not a substitute). Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.
Analysis population: Evaluable patients randomized to either arm A or arm B who had cytogenetic response data
Groups in this outcome
Arm A (Lenalidomide; Randomization)
Patients receive lenalidomide PO QD on days 1-21.
Arm B (Lenalidomide + Epoetin Alfa; Randomization)
Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
| Group | Source count |
|---|---|
| Arm A (Lenalidomide; Randomization) | 55 |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide; Randomization) | 0.07 | Not reported | 0.02 | 0.18 | Not reported |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 0.10 | Not reported | 0.03 | 0.21 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.02
- upper Limit
- 0.18
- value
- 0.07
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 0.21
- value
- 0.10
- denoms
- counts
- group Id
- OG000
- value
- 55
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- Evaluation of cytogenetic response requires 20 analyzable metaphases when using conventional techniques. Analysis of data will require 20 metaphases before and after treatment, which must be done on bone marrow only (peripheral blood is not a substitute). Fluorescent in situ hybridization (FISH) may be used as a supplement to follow a specifically defined cytogenetic abnormality, but it is not a substitute for conventional cytogenetic studies. Cytogenetic response is defined as follows: Complete response: Restoration of a normal karyotype in patients with a documented pre-existing clonal (\>2 metaphases abnormal) chromosome abnormalities. Partial response: \> 50% reduction in the percentage of bone marrow metaphases with only clonal abnormality.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive lenalidomide PO QD on days 1-21.
- id
- OG000
- title
- Arm A (Lenalidomide; Randomization)
- description
- Patients receive lenalidomide PO QD on days 1-21 and epoetin alfa SC once weekly.
- id
- OG001
- title
- Arm B (Lenalidomide + Epoetin Alfa; Randomization)
- param Type
- NUMBER
- population Description
- Evaluable patients randomized to either arm A or arm B who had cytogenetic response data
- reporting Status
- POSTED
- time Frame
- Assessed at baseline and after completion of 16 weeks of treatment
- title
- Proportion of Patients With Cytogenetic Response
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice