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NCT00843882 · OUTCOME

Proportion of Patients With 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
NUMBER
Unit
proportion of participants
Interval / dispersion
90% Confidence Interval
Time frame
Assessed after completion of 16 weeks of treatment

What was measured

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: 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 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)96
Arm B (Lenalidomide + Epoetin Alfa; Randomization)99

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Lenalidomide; Randomization)0.115Not reported0.0660.183Not reported
Arm B (Lenalidomide + Epoetin Alfa; Randomization)0.283Not reported0.2090.367Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.066
        upper Limit
        0.183
        value
        0.115
      2. group Id
        OG001
        lower Limit
        0.209
        upper Limit
        0.367
        value
        0.283
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      99
    units
    Participants
description
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
90% 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
NUMBER
population Description
Evaluable patients randomized to either arm A or arm B
reporting Status
POSTED
time Frame
Assessed after completion of 16 weeks of treatment
title
Proportion of Patients With Major Erythroid Response (MER)
type
PRIMARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice