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NCT00732641 · OUTCOME

Quality of Life

Peginterferon α-2b as a Maintenance Therapy in Participants With Multiple Myeloma Who Responded to Induction Therapy (P01972-AM7) · Source last updated 2017-04-04

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

Measure
MEAN
Unit
Score on a scale
Interval / dispersion
Standard Deviation
Time frame
Screening and Last Observation (up to 5 years)

What was measured

Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).

Analysis population: Intent-to-treat population (those who received at least one dose of study drug). The number of participants analyzed varied depending on the number of observations available for each category.

Groups in this outcome

Peginterferon α-2b

Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.

No Treatment

Participants were observed and received no treatment

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

Analysis denominator · Participants

GroupSource count
Peginterferon α-2b122
No Treatment121

Reported measurements

Global Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b44.012.5Not reportedNot reportedNot reported
No Treatment45.210.8Not reportedNot reportedNot reported
Global Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b41.412.5Not reportedNot reportedNot reported
No Treatment42.010.6Not reportedNot reportedNot reported
Global Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-2.815.5Not reportedNot reportedNot reported
No Treatment-2.613.1Not reportedNot reportedNot reported
Physical Functioning Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b80.322.9Not reportedNot reportedNot reported
No Treatment74.025.6Not reportedNot reportedNot reported
Physical Functioning Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b68.929.0Not reportedNot reportedNot reported
No Treatment68.727.4Not reportedNot reportedNot reported
Physical Functioning Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-11.428.5Not reportedNot reportedNot reported
No Treatment-6.929.2Not reportedNot reportedNot reported
Role Functioning Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b85.418.8Not reportedNot reportedNot reported
No Treatment77.625.0Not reportedNot reportedNot reported
Role Functioning Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b71.030.1Not reportedNot reportedNot reported
No Treatment72.227.1Not reportedNot reportedNot reported
Role Functioning Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-14.128.2Not reportedNot reportedNot reported
No Treatment-8.031.0Not reportedNot reportedNot reported
Emotional Functioning Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b83.715.9Not reportedNot reportedNot reported
No Treatment80.919.5Not reportedNot reportedNot reported
Emotional Functioning Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b72.623.7Not reportedNot reportedNot reported
No Treatment74.620.7Not reportedNot reportedNot reported
Emotional Functioning Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-10.619.1Not reportedNot reportedNot reported
No Treatment-8.022.2Not reportedNot reportedNot reported
Cognitive Functioning Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b90.314.9Not reportedNot reportedNot reported
No Treatment89.316.4Not reportedNot reportedNot reported
Cognitive Functioning Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b82.920.9Not reportedNot reportedNot reported
No Treatment84.219.3Not reportedNot reportedNot reported
Cognitive Functioning Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-7.217.8Not reportedNot reportedNot reported
No Treatment-7.516.9Not reportedNot reportedNot reported
Social Functioning Score (baseline)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b86.020.2Not reportedNot reportedNot reported
No Treatment82.324.0Not reportedNot reportedNot reported
Social Functioning Score (last observation)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b79.725.9Not reportedNot reportedNot reported
No Treatment82.624.4Not reportedNot reportedNot reported
Social Functioning Score (change)
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Peginterferon α-2b-6.430.2Not reportedNot reportedNot reported
No Treatment-1.927.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.5
        value
        44.0
      2. group Id
        OG001
        spread
        10.8
        value
        45.2
    title
    Global Score (baseline)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.5
        value
        41.4
      2. group Id
        OG001
        spread
        10.6
        value
        42.0
    title
    Global Score (last observation)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.5
        value
        -2.8
      2. group Id
        OG001
        spread
        13.1
        value
        -2.6
    title
    Global Score (change)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.9
        value
        80.3
      2. group Id
        OG001
        spread
        25.6
        value
        74.0
    title
    Physical Functioning Score (baseline)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.0
        value
        68.9
      2. group Id
        OG001
        spread
        27.4
        value
        68.7
    title
    Physical Functioning Score (last observation)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.5
        value
        -11.4
      2. group Id
        OG001
        spread
        29.2
        value
        -6.9
    title
    Physical Functioning Score (change)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.8
        value
        85.4
      2. group Id
        OG001
        spread
        25.0
        value
        77.6
    title
    Role Functioning Score (baseline)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.1
        value
        71.0
      2. group Id
        OG001
        spread
        27.1
        value
        72.2
    title
    Role Functioning Score (last observation)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.2
        value
        -14.1
      2. group Id
        OG001
        spread
        31.0
        value
        -8.0
    title
    Role Functioning Score (change)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.9
        value
        83.7
      2. group Id
        OG001
        spread
        19.5
        value
        80.9
    title
    Emotional Functioning Score (baseline)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.7
        value
        72.6
      2. group Id
        OG001
        spread
        20.7
        value
        74.6
    title
    Emotional Functioning Score (last observation)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.1
        value
        -10.6
      2. group Id
        OG001
        spread
        22.2
        value
        -8.0
    title
    Emotional Functioning Score (change)
denoms
  1. counts
    1. group Id
      OG000
      value
      122
    2. group Id
      OG001
      value
      121
    units
    Participants
description
Participants were given the Europen Organization for Research in Cancer Therapy Quality of Life Questionnaire (EORTC QLQ), version 2.0, which consisted of 30 questions. The questionnaire evaluated global health/quality of life and incorporated five functional scales (Physical; Role; Emotional; Cognitive; Social). All of the scales ranged in score from 0 (worst) to 100 (best).
dispersion Type
Standard Deviation
groups
  1. description
    Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.
    id
    OG000
    title
    Peginterferon α-2b
  2. description
    Participants were observed and received no treatment
    id
    OG001
    title
    No Treatment
param Type
MEAN
population Description
Intent-to-treat population (those who received at least one dose of study drug). The number of participants analyzed varied depending on the number of observations available for each category.
reporting Status
POSTED
time Frame
Screening and Last Observation (up to 5 years)
title
Quality of Life
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice