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NCT00872521 · OUTCOME

Assessment of Quality of Life (AQoL) Scores

A Study of Efficacy of Treatment With Bortezomib (in Combination With Doxorubicin and Dexamethasone) in Previously Untreated Patients With Multiple Myeloma · Source last updated 2014-05-16

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
Up to 2 years

What was measured

The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).

Analysis population: Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD

Groups in this outcome

1q21 Not Amplified

Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

1q21 Amplified

Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

Failed/Missing

Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

Total

Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.

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

Analysis denominator · Participants

GroupSource count
1q21 Not Amplified42
1q21 Amplified19
Failed/Missing8
Total69

Reported measurements

Source class 1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1q21 Not Amplified0.05165960.2769184Not reportedNot reportedNot reported
1q21 Amplified0.00686950.3366162Not reportedNot reportedNot reported
Failed/Missing0.12671450.1839149Not reportedNot reportedNot reported
Total0.04802810.2844673Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2769184
        value
        0.0516596
      2. group Id
        OG001
        spread
        0.3366162
        value
        0.0068695
      3. group Id
        OG002
        spread
        0.1839149
        value
        0.1267145
      4. group Id
        OG003
        spread
        0.2844673
        value
        0.0480281
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      69
    units
    Participants
description
The AQoL is a multi-attribute utility health-related quality of life (HRQoL) instrument. It combines the 4 dimensions of independent living, relationships, senses and mental health into a single utility score. The AQoL instrument scores between 1 (best HRQoL) and -0.04 (worst possible HRQoL).
dispersion Type
Standard Deviation
groups
  1. description
    Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG000
    title
    1q21 Not Amplified
  2. description
    Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG001
    title
    1q21 Amplified
  3. description
    Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG002
    title
    Failed/Missing
  4. description
    Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
    id
    OG003
    title
    Total
param Type
MEAN
population Description
Intent-to-treat (ITT) population - All participants who were screened and received at least one dose of PAD
reporting Status
POSTED
time Frame
Up to 2 years
title
Assessment of Quality of Life (AQoL) Scores
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice