TriangleNCT00843882 · OUTCOME
Pretreatment Endogenous Erythropoietin Level
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- mU/mL
- Interval / dispersion
- Full Range
- Time frame
- Assessed at baseline and after completion of 16 weeks of treatment
What was measured
Pretreatment endogenous erythropoietin level was assessed at baseline. The association between pretreatment endogenous erythropoietin level and major erythroid response was evaluated among patients who received lenalidomide alone. Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
Analysis population: All patients randomized to arm A and all patients with 5q31.1 deletion that received lenalidomide alone
Groups in this outcome
Arm A Patients With Major Erythroid Response
Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
Arm A Patients Without Major Erythroid Response
Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
| Group | Source count |
|---|---|
| Arm A Patients With Major Erythroid Response | 36 |
| Arm A Patients Without Major Erythroid Response | 105 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A Patients With Major Erythroid Response | 514.5 | Not reported | 82 | 3405 | Not reported |
| Arm A Patients Without Major Erythroid Response | 150 | Not reported | 11 | 3048 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Method
- Wilcoxon (Mann-Whitney)
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Method
- Wilcoxon (Mann-Whitney)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82
- upper Limit
- 3405
- value
- 514.5
- group Id
- OG001
- lower Limit
- 11
- upper Limit
- 3048
- value
- 150
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 105
- units
- Participants
- description
- Pretreatment endogenous erythropoietin level was assessed at baseline. The association between pretreatment endogenous erythropoietin level and major erythroid response was evaluated among patients who received lenalidomide alone. Major erythroid response is defined as transfusion-independence for ≥ 8 consecutive weeks for patients who were red blood cell transfusion-dependent at baseline AND a ≥ 1 g/dL hemoglobin rise compared to mean pre-transfusion baseline value; or a \> 2 g/dL rise in hemoglobin without transfusion for non-transfusion dependent patients.
- dispersion Type
- Full Range
- groups
- description
- Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
- id
- OG000
- title
- Arm A Patients With Major Erythroid Response
- description
- Patients receive lenalidomide PO QD on days 1-21 and achieve major erythroid response.
- id
- OG001
- title
- Arm A Patients Without Major Erythroid Response
- param Type
- MEDIAN
- population Description
- All patients randomized to arm A and all patients with 5q31.1 deletion that received lenalidomide alone
- reporting Status
- POSTED
- time Frame
- Assessed at baseline and after completion of 16 weeks of treatment
- title
- Pretreatment Endogenous Erythropoietin Level
- type
- SECONDARY
- unit Of Measure
- mU/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice