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NCT01311687 · OUTCOME

Change From Baseline in the EORTC QLQ-C30 Pain Domain

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24

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
Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6

What was measured

The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom).

Analysis population: PRO population with available data at Baseline and each time point

Groups in this outcome

Pomalidomide Plus Low-Dose Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

High-Dose Dexamethasone

Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone289
High-Dose Dexamethasone144

Reported measurements

Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone210
High-Dose Dexamethasone92
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-2.7025.74Not reportedNot reportedNot reported
High-Dose Dexamethasone0.3625.32Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone177
High-Dose Dexamethasone53
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-3.5829.62Not reportedNot reportedNot reported
High-Dose Dexamethasone2.8325.47Not reportedNot reportedNot reported
Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone159
High-Dose Dexamethasone33
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-2.4130.52Not reportedNot reportedNot reported
High-Dose Dexamethasone3.0325.84Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone132
High-Dose Dexamethasone27
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-1.6428.00Not reportedNot reportedNot reported
High-Dose Dexamethasone2.4731.59Not reportedNot reportedNot reported
Cycle 6, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone118
High-Dose Dexamethasone18
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-2.4030.99Not reportedNot reportedNot reported
High-Dose Dexamethasone10.1923.67Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.74
        value
        -2.70
      2. group Id
        OG001
        spread
        25.32
        value
        0.36
    denoms
    1. counts
      1. group Id
        OG000
        value
        210
      2. group Id
        OG001
        value
        92
      units
      Participants
    title
    Cycle 2, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.62
        value
        -3.58
      2. group Id
        OG001
        spread
        25.47
        value
        2.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        177
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    Cycle 3, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.52
        value
        -2.41
      2. group Id
        OG001
        spread
        25.84
        value
        3.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        33
      units
      Participants
    title
    Cycle 4, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.00
        value
        -1.64
      2. group Id
        OG001
        spread
        31.59
        value
        2.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.99
        value
        -2.40
      2. group Id
        OG001
        spread
        23.67
        value
        10.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        18
      units
      Participants
    title
    Cycle 6, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      289
    2. group Id
      OG001
      value
      144
    units
    Participants
description
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate reductions in pain (i.e. improvement in symptom) and positive values indicate increases in pain (i.e. worsening of symptom).
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    OG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    OG001
    title
    High-Dose Dexamethasone
param Type
MEAN
population Description
PRO population with available data at Baseline and each time point
reporting Status
POSTED
time Frame
Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
title
Change From Baseline in the EORTC QLQ-C30 Pain Domain
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice