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NCT01286077 · OUTCOME

Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)

Velcade Consolidation Bone Study · Source last updated 2016-05-30

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

Measure
MEAN
Unit
millimeter (mm)
Interval / dispersion
Standard Deviation
Time frame
Baseline up to end of study (approximately 4 years 7 months)

What was measured

Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter \[mm\]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.

Analysis population: FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.

Groups in this outcome

Bortezomib

bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles

Non-treated Control

no treatment, observation only

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

Analysis denominator · Participants

GroupSource count
Bortezomib46
Non-treated Control47

Reported measurements

Source class 1
Values in millimeter (mm) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib-0.318.4Not reportedNot reportedNot reported
Non-treated Control2.922.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.4
        value
        -0.3
      2. group Id
        OG001
        spread
        22.6
        value
        2.9
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      47
    units
    Participants
description
Subjects were asked to rate their general state of health on a Visual analog scale (in millimeter \[mm\]) ranging from 0 (worst state of health) to 100 (best conceivable state of health) mm.
dispersion Type
Standard Deviation
groups
  1. description
    bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
    id
    OG000
    title
    Bortezomib
  2. description
    no treatment, observation only
    id
    OG001
    title
    Non-treated Control
param Type
MEAN
population Description
FAS included all the randomized subjects who were eligible for efficacy analysis, that is, excluding subjects who did not have baseline and/or post-baseline data. Missing data was imputed by last observation carried forward (LOCF) method.
reporting Status
POSTED
time Frame
Baseline up to end of study (approximately 4 years 7 months)
title
Change From Baseline in Quality of Life Assessed by Euro Quality of Life (EQ-5D)
type
SECONDARY
unit Of Measure
millimeter (mm)

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

Preserved source evidence · Not medical advice