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NCT00540644 · OUTCOME

Quality of Life Using the FACT-G Data

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2016-06-21

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
baseline and after last cycle (up to 6 cycles)

What was measured

Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome

Analysis population: All patients enrolled and received treatment with a baseline and post-baseline measurement.

Groups in this outcome

Original Study - Revlimid, Cyclophosphamide, Prednisone

Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Extension - Revlimid, Cyclophosphamide, Prednisone

Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

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

Analysis denominator · Participants

GroupSource count
Original Study - Revlimid, Cyclophosphamide, Prednisone29
Extension - Revlimid, Cyclophosphamide, Prednisone15

Reported measurements

Physical Well-Being Change from Baseline
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Original Study - Revlimid, Cyclophosphamide, Prednisone1.576.20Not reportedNot reportedNot reported
Extension - Revlimid, Cyclophosphamide, Prednisone-2.816.14Not reportedNot reportedNot reported
Social/Family Well-Being Change from Baseline
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Original Study - Revlimid, Cyclophosphamide, Prednisone-0.035.08Not reportedNot reportedNot reported
Extension - Revlimid, Cyclophosphamide, Prednisone-0.233.53Not reportedNot reportedNot reported
Emotional Well-Beling Change from Baseline
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Original Study - Revlimid, Cyclophosphamide, Prednisone2.523.95Not reportedNot reportedNot reported
Extension - Revlimid, Cyclophosphamide, Prednisone0.603.22Not reportedNot reportedNot reported
Functional Well-Being Change from Baseline
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Original Study - Revlimid, Cyclophosphamide, Prednisone3.385.33Not reportedNot reportedNot reported
Extension - Revlimid, Cyclophosphamide, Prednisone-1.174.97Not reportedNot reportedNot reported
FACT-G Change from Baseline
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Original Study - Revlimid, Cyclophosphamide, Prednisone7.4413.07Not reportedNot reportedNot reported
Extension - Revlimid, Cyclophosphamide, Prednisone-3.6110.92Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.20
        value
        1.57
      2. group Id
        OG001
        spread
        6.14
        value
        -2.81
    title
    Physical Well-Being Change from Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.08
        value
        -0.03
      2. group Id
        OG001
        spread
        3.53
        value
        -0.23
    title
    Social/Family Well-Being Change from Baseline
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.95
        value
        2.52
      2. group Id
        OG001
        spread
        3.22
        value
        0.60
    title
    Emotional Well-Beling Change from Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.33
        value
        3.38
      2. group Id
        OG001
        spread
        4.97
        value
        -1.17
    title
    Functional Well-Being Change from Baseline
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.07
        value
        7.44
      2. group Id
        OG001
        spread
        10.92
        value
        -3.61
    title
    FACT-G Change from Baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Change from baseline FACT-G scores. The quality of life questionnaire (FACT-G) was given at various timepoints during the study. The values for change from baseline to endpoint are provided. Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28) ; Fact-G score=sum of PWB, SWB, EWB, FWB, point range 0-108. Note: The higher the score, the better the outcome
dispersion Type
Standard Deviation
groups
  1. description
    Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
    id
    OG000
    title
    Original Study - Revlimid, Cyclophosphamide, Prednisone
  2. description
    Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
    id
    OG001
    title
    Extension - Revlimid, Cyclophosphamide, Prednisone
param Type
MEAN
population Description
All patients enrolled and received treatment with a baseline and post-baseline measurement.
reporting Status
POSTED
time Frame
baseline and after last cycle (up to 6 cycles)
title
Quality of Life Using the FACT-G Data
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice