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NCT01023308 · OUTCOME

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma · Source last updated 2020-03-17

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

Measure
LEAST_SQUARES_MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
12, 24 and 48 weeks

What was measured

Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.

Analysis population: Full Analysis Set

Groups in this outcome

Panobinostat + Bortezomib

Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.

Placebo + Bortezomib

Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.

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

Analysis denominator · Participants

GroupSource count
Panobinostat + Bortezomib387
Placebo + Bortezomib381

Reported measurements

Disease Symptom wk 12 change baseline (n=215,243)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-4.795Not reported-6.76-2.83Not reported
Placebo + Bortezomib-4.865Not reported-6.75-2.98Not reported
Disease Symptom wk 24 change baseline (n=148,177)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-4.401Not reported-6.53-2.27Not reported
Placebo + Bortezomib-6.797Not reported-8.79-4.81Not reported
Disease Symptom wk 48 change baseline (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.836Not reported-6.76-1.084Not reported
Placebo + Bortezomib-6.626Not reported-11.1-2.12Not reported
Side effects of treatment wk 12 chge (n=213,242)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib8.162Not reported6.5109.814Not reported
Placebo + Bortezomib5.524Not reported3.9337.115Not reported
Side effects of treatment wk 24 chge (n=148,175)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib9.016Not reported6.95511.08Not reported
Placebo + Bortezomib7.731Not reported5.7959.668Not reported
Side effects of treatment wk 48 chge (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib3.357Not reported0.4426.273Not reported
Placebo + Bortezomib3.654Not reported0.3526.956Not reported
Future perspective wk 12 chge (n=214,242)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib5.319Not reported2.8937.744Not reported
Placebo + Bortezomib6.194Not reported3.8548.533Not reported
Future perspective wk 24 chge (n=148,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib3.877Not reported0.9776.778Not reported
Placebo + Bortezomib5.839Not reported3.1038.575Not reported
Future perspective wk 48 chge (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib4.331Not reported-.1428.804Not reported
Placebo + Bortezomib6.951Not reported1.80712.10Not reported
Body image wk 12 chge (n=213,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-7.178Not reported-10.5-3.87Not reported
Placebo + Bortezomib-6.22Not reported-9.41-3.03Not reported
Body image wk 24 chge (n=147,175)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-11.463Not reported-15.3-7.66Not reported
Placebo + Bortezomib-7.358Not reported-10.9-3.81Not reported
Body image wk 48 chge (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.161Not reported-7.733.410Not reported
Placebo + Bortezomib-4.666Not reported-11.11.729Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.76
        upper Limit
        -2.83
        value
        -4.795
      2. group Id
        OG001
        lower Limit
        -6.75
        upper Limit
        -2.98
        value
        -4.865
    title
    Disease Symptom wk 12 change baseline (n=215,243)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.53
        upper Limit
        -2.27
        value
        -4.401
      2. group Id
        OG001
        lower Limit
        -8.79
        upper Limit
        -4.81
        value
        -6.797
    title
    Disease Symptom wk 24 change baseline (n=148,177)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.76
        upper Limit
        -1.084
        value
        -2.836
      2. group Id
        OG001
        lower Limit
        -11.1
        upper Limit
        -2.12
        value
        -6.626
    title
    Disease Symptom wk 48 change baseline (n=37,26)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.510
        upper Limit
        9.814
        value
        8.162
      2. group Id
        OG001
        lower Limit
        3.933
        upper Limit
        7.115
        value
        5.524
    title
    Side effects of treatment wk 12 chge (n=213,242)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.955
        upper Limit
        11.08
        value
        9.016
      2. group Id
        OG001
        lower Limit
        5.795
        upper Limit
        9.668
        value
        7.731
    title
    Side effects of treatment wk 24 chge (n=148,175)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.442
        upper Limit
        6.273
        value
        3.357
      2. group Id
        OG001
        lower Limit
        0.352
        upper Limit
        6.956
        value
        3.654
    title
    Side effects of treatment wk 48 chge (n=37,26)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.893
        upper Limit
        7.744
        value
        5.319
      2. group Id
        OG001
        lower Limit
        3.854
        upper Limit
        8.533
        value
        6.194
    title
    Future perspective wk 12 chge (n=214,242)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.977
        upper Limit
        6.778
        value
        3.877
      2. group Id
        OG001
        lower Limit
        3.103
        upper Limit
        8.575
        value
        5.839
    title
    Future perspective wk 24 chge (n=148,176)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -.142
        upper Limit
        8.804
        value
        4.331
      2. group Id
        OG001
        lower Limit
        1.807
        upper Limit
        12.10
        value
        6.951
    title
    Future perspective wk 48 chge (n=37,26)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.5
        upper Limit
        -3.87
        value
        -7.178
      2. group Id
        OG001
        lower Limit
        -9.41
        upper Limit
        -3.03
        value
        -6.22
    title
    Body image wk 12 chge (n=213,240)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -15.3
        upper Limit
        -7.66
        value
        -11.463
      2. group Id
        OG001
        lower Limit
        -10.9
        upper Limit
        -3.81
        value
        -7.358
    title
    Body image wk 24 chge (n=147,175)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.73
        upper Limit
        3.410
        value
        -2.161
      2. group Id
        OG001
        lower Limit
        -11.1
        upper Limit
        1.729
        value
        -4.666
    title
    Body image wk 48 chge (n=37,26)
denoms
  1. counts
    1. group Id
      OG000
      value
      387
    2. group Id
      OG001
      value
      381
    units
    Participants
description
Higher values in the disease symptoms and side effects of treatment scores indicate worsening. Higher scores in the future perspective and body image scores indicate improvement. LS Means and SEM are estimated from the repeated measures model. Following factors and covariates are included in the repeated measurement model: time, treatment, treatment by time interaction, number of prior lines of anti-MM therapy (1/ 2 and 3), prior use of BTZ (Yes/ No), baseline score.Disease Symptom is the sum of 20 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-MY20 have the same score range of 0 -100. Decrease in symptom scores from baseline indicate improvement in symptoms.
dispersion Type
95% Confidence Interval
groups
  1. description
    Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    OG000
    title
    Panobinostat + Bortezomib
  2. description
    Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    OG001
    title
    Placebo + Bortezomib
param Type
LEAST_SQUARES_MEAN
population Description
Full Analysis Set
reporting Status
POSTED
time Frame
12, 24 and 48 weeks
title
European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC) QLQ-MY20-Change From Baseline by Treatment Group
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice