NCT00843882 · OUTCOME
Time to Major Erythroid Response (MER)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment
What was measured
Time to major erythroid response (MER) is defined in responders as the time from randomization to the documented date of MER. For transfusion independent patients, the date of MER is the first date of the elevation in hemoglobin level of more than 2 g/dL that has been sustained for at least 8 weeks. For transfusion dependent patients, the date of MER is the beginning date of the time interval of transfusion independence that has been sustained for at least eight weeks.
Analysis population: Only evaluable patients who achieved MER among randomized patients were included in this analysis.
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) | 11 |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 28 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Lenalidomide; Randomization) | 3.6 | Not reported | 2.1 | 5.5 | Not reported |
| Arm B (Lenalidomide + Epoetin Alfa; Randomization) | 3.7 | Not reported | 1.0 | 10.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 5.5
- value
- 3.6
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- 10.6
- value
- 3.7
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 28
- units
- Participants
- description
- Time to major erythroid response (MER) is defined in responders as the time from randomization to the documented date of MER. For transfusion independent patients, the date of MER is the first date of the elevation in hemoglobin level of more than 2 g/dL that has been sustained for at least 8 weeks. For transfusion dependent patients, the date of MER is the beginning date of the time interval of transfusion independence that has been sustained for at least eight weeks.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Only evaluable patients who achieved MER among randomized patients were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment
- title
- Time to Major Erythroid Response (MER)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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