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NCT00843882 · OUTCOME

Duration of Major Erythroid Response (MER)

Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia · Source last updated 2026-09-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed every cycle during treatment and then 3 and 6 months after last protocol treatment

What was measured

Duration of major erythroid response (MER) is defined as the time interval between the documented date of MER and the earliest date of resumption of red blood cell transfusions ≥ 2 units in an 8-week period, a reduction in hemoglobin concentration ≥ 2 g/dL in the absence of acute infection, gastrointestinal bleeding and hemolysis, or death.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Lenalidomide; Randomization)11
Arm B (Lenalidomide + Epoetin Alfa; Randomization)28

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Lenalidomide; Randomization)13Not reported2.175Not reported
Arm B (Lenalidomide + Epoetin Alfa; Randomization)23.8Not reported8.5NAThe upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        75
        value
        13
      2. comment
        The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
        group Id
        OG001
        lower Limit
        8.5
        upper Limit
        NA
        value
        23.8
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      28
    units
    Participants
description
Duration of major erythroid response (MER) is defined as the time interval between the documented date of MER and the earliest date of resumption of red blood cell transfusions ≥ 2 units in an 8-week period, a reduction in hemoglobin concentration ≥ 2 g/dL in the absence of acute infection, gastrointestinal bleeding and hemolysis, or death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive lenalidomide PO QD on days 1-21.
    id
    OG000
    title
    Arm A (Lenalidomide; Randomization)
  2. 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
Duration of Major Erythroid Response (MER)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice