TriangleNCT00843882 · OUTCOME
Proportion of Patients With Bone Marrow 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
- 90% Confidence Interval
- Time frame
- Assessed at 16 weeks
What was measured
Bone marrow response includes complete remission (CR) and partial remission (PR). Complete remission (CR): Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. When erythroid precursors constitute \< 50% of bone marrow nucleated cells, the percent of blasts is based on all nucleated cells; when there are ≥ 50% erythroid cells, the percent blasts should be based on the non-erythroid cells. Partial remission (PR): All of the CR criteria (if abnormal prior to treatment), except blasts decreased by 50% over pre-treatment, or a less advanced Myelodysplastic Syndromes (MDS) World Health Organization (WHO) classification than pretreatment. Cellularity and morphology are not relevant.
Analysis population: Evaluable patients randomized to either arm A or arm B
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) | 96 |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 99 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide; Randomization) | 0.01 | Not reported | 0.0006 | 0.049 | Not reported |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 0.03 | Not reported | 0.008 | 0.077 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0006
- upper Limit
- 0.049
- value
- 0.01
- group Id
- OG001
- lower Limit
- 0.008
- upper Limit
- 0.077
- value
- 0.03
- denoms
- counts
- group Id
- OG000
- value
- 96
- group Id
- OG001
- value
- 99
- units
- Participants
- description
- Bone marrow response includes complete remission (CR) and partial remission (PR). Complete remission (CR): Bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia. When erythroid precursors constitute \< 50% of bone marrow nucleated cells, the percent of blasts is based on all nucleated cells; when there are ≥ 50% erythroid cells, the percent blasts should be based on the non-erythroid cells. Partial remission (PR): All of the CR criteria (if abnormal prior to treatment), except blasts decreased by 50% over pre-treatment, or a less advanced Myelodysplastic Syndromes (MDS) World Health Organization (WHO) classification than pretreatment. Cellularity and morphology are not relevant.
- dispersion Type
- 90% 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
- reporting Status
- POSTED
- time Frame
- Assessed at 16 weeks
- title
- Proportion of Patients With Bone Marrow Response
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice