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NCT00405756 · OUTCOME

Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day 0), Months 4, 7, 10, 13, 16

What was measured

Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.

Analysis population: Intent to treat population

Groups in this outcome

MPR+R

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPR+p

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPp+p

Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

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

Analysis denominator · Participants

GroupSource count
MPR+R152
MPR+p153
MPp+p154

Reported measurements

Cycle 4 - approximately Month 4 (n=115,125,128)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R0.321.51Not reportedNot reportedNot reported
MPR+p-2.021.33Not reportedNot reportedNot reported
MPp+p1.316.68Not reportedNot reportedNot reported
Cycle 7 - approximately Month 7 (n=98,111,113)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R2.922.31Not reportedNot reportedNot reported
MPR+p0.117.33Not reportedNot reportedNot reported
MPp+p0.718.42Not reportedNot reportedNot reported
Cycle 10 - approximately Month 10 (n=87,92,97)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R1.022.64Not reportedNot reportedNot reported
MPR+p-4.419.89Not reportedNot reportedNot reported
MPp+p-2.720.65Not reportedNot reportedNot reported
Cycle 13 - approximately Month 13 (n=73,73,83)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R-0.021.34Not reportedNot reportedNot reported
MPR+p-3.023.78Not reportedNot reportedNot reported
MPp+p-1.417.69Not reportedNot reportedNot reported
Cycle 16 - approximately Month 16 (n=63,52,63)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R0.322.29Not reportedNot reportedNot reported
MPR+p-3.527.48Not reportedNot reportedNot reported
MPp+p-4.018.13Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.51
        value
        0.3
      2. group Id
        OG001
        spread
        21.33
        value
        -2.0
      3. group Id
        OG002
        spread
        16.68
        value
        1.3
    title
    Cycle 4 - approximately Month 4 (n=115,125,128)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.31
        value
        2.9
      2. group Id
        OG001
        spread
        17.33
        value
        0.1
      3. group Id
        OG002
        spread
        18.42
        value
        0.7
    title
    Cycle 7 - approximately Month 7 (n=98,111,113)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.64
        value
        1.0
      2. group Id
        OG001
        spread
        19.89
        value
        -4.4
      3. group Id
        OG002
        spread
        20.65
        value
        -2.7
    title
    Cycle 10 - approximately Month 10 (n=87,92,97)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.34
        value
        -0.0
      2. group Id
        OG001
        spread
        23.78
        value
        -3.0
      3. group Id
        OG002
        spread
        17.69
        value
        -1.4
    title
    Cycle 13 - approximately Month 13 (n=73,73,83)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.29
        value
        0.3
      2. group Id
        OG001
        spread
        27.48
        value
        -3.5
      3. group Id
        OG002
        spread
        18.13
        value
        -4.0
    title
    Cycle 16 - approximately Month 16 (n=63,52,63)
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      153
    3. group Id
      OG002
      value
      154
    units
    Participants
description
Data as of 11 May 2010 cutoff. EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.
dispersion Type
Standard Deviation
groups
  1. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG000
    title
    MPR+R
  2. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG001
    title
    MPR+p
  3. description
    Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG002
    title
    MPp+p
param Type
MEAN
population Description
Intent to treat population
reporting Status
POSTED
time Frame
Baseline (Day 0), Months 4, 7, 10, 13, 16
title
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Congitive Functioning Scale
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice