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NCT01023308 · OUTCOME

European Organization for Research and Treatment of Cancer Multiple Myeloma Module (EORTC ) QLQ-C30 - Summary Statistics 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

The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in 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

Global health wk 12 change baseline (n=216,239)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-9.853Not reported-12.50-7.20Not reported
Placebo + Bortezomib-4.044Not reported-6.60-1.49Not reported
Global health wk 24 change baseline (n=150,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-7.867Not reported-10.7-5.08Not reported
Placebo + Bortezomib-1.518Not reported-4.11-1.075Not reported
Global health wk 48 change baseline (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.986Not reported-7.211.237Not reported
Placebo + Bortezomib4.345Not reported-0.4169.106Not reported
Physical functioning wk 12 chge (n=217,242)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-9.67Not reported-12.00-7.38Not reported
Placebo + Bortezomib-5.393Not reported-76.3-3.16Not reported
Physical functioning wk 24 chge (n=151,177)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-9.516Not reported-12.20-7.38Not reported
Placebo + Bortezomib-6.456Not reported-8.98-3.93Not reported
Physical functioning wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.88Not reported-6.410.651Not reported
Placebo + Bortezomib2.037Not reported-2.076.147Not reported
Role functioning wk 12 chge (n=215,237)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-11.159Not reported-14.6-7.74Not reported
Placebo + Bortezomib-6.762Not reported-10.1-3.45Not reported
Role functioning wk 24 chge (n=150,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-11.875Not reported-15.7-8.01Not reported
Placebo + Bortezomib-11.263Not reported-14.9-7.61Not reported
Role functioning wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-5.927Not reported-11.4-0.424Not reported
Placebo + Bortezomib-0.401Not reported-6.735.924Not reported
Cognitive functioning wk 12 chge (n=216,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-4.464Not reported-6.89-2.04Not reported
Placebo + Bortezomib-1.023Not reported-3.361.318Not reported
Cognitive functioning wk 24 chge (n=149,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-6.053Not reported-8.87-3.24Not reported
Placebo + Bortezomib-3.542Not reported-6.22-0.865Not reported
Cognitive functioning wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-5.568Not reported-9.79-1.34Not reported
Placebo + Bortezomib-4.042Not reported-8.990.902Not reported
Social functioning wk 12 chge (n=216,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-8.502Not reported-11.6-5.44Not reported
Placebo + Bortezomib-3.991Not reported-6.971.02Not reported
Social functioning wk 24 chge (n=148,171)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-8.925Not reported-12.4-5.42Not reported
Placebo + Bortezomib-6.338Not reported-9.66-3.02Not reported
Social functioning wk 48 chge (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-6.104Not reported-11.0-1.22Not reported
Placebo + Bortezomib4.617Not reported-0.93010.16Not reported
Fatigue wk 12 chge (n=217,241)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib15.122Not reported12.2717.98Not reported
Placebo + Bortezomib7.939Not reported5.17410.70Not reported
Fatigue wk 24 chge (n=151,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib12.677Not reported9.41915.94Not reported
Placebo + Bortezomib9.203Not reported6.13612.27Not reported
Fatigue wk 48 chge(n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib4.646Not reported0.0869.206Not reported
Placebo + Bortezomib-2.625Not reported-7.882.628Not reported
Dyspnea wk 12 chge (n=217,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib13.964Not reported10.6017.33Not reported
Placebo + Bortezomib6.266Not reported3.0129.521Not reported
Dyspnea wk 24 chge (n=151,177)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib7.939Not reported4.63911.24Not reported
Placebo + Bortezomib5.308Not reported2.2218.394Not reported
Dyspnea wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib4.118Not reported-1.589.813Not reported
Placebo + Bortezomib2.82Not reported-3.889.523Not reported
Insomnia wk 12 chge (n=216,239)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib6.283Not reported2.8519.715Not reported
Placebo + Bortezomib7.625Not reported4.33110.92Not reported
Insomnia wk 24 chge (n=149,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib10.023Not reported6.03814.01Not reported
Placebo + Bortezomib6.104Not reported2.3819.827Not reported
Insomnia wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.464Not reported-8.743.811Not reported
Placebo + Bortezomib-3.442Not reported-10.94.017Not reported
Appetite loss wk 12 chge (n=217,239)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib15.167Not reported11.6018.74Not reported
Placebo + Bortezomib5.383Not reported1.9258.841Not reported
Appetite loss wk 24 chge (n=151,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib16.574Not reported12.3920.76Not reported
Placebo + Bortezomib5.861Not reported1.9189.804Not reported
Appetite loss wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib3.999Not reported-2.0810.07Not reported
Placebo + Bortezomib-2.963Not reported-9.994.061Not reported
Constipation wk 12 chge (n=215,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib4.135Not reported0.6677.603Not reported
Placebo + Bortezomib6.42Not reported3.1049.735Not reported
Constipation wk 24 chge (n=151,177)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-0.153Not reported-3.643.337Not reported
Placebo + Bortezomib0.524Not reported-2.735.782Not reported
Constipation wk 48 chge (n=38,25)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-0.358Not reported-5.574.851Not reported
Placebo + Bortezomib-0.946Not reported-7.265.373Not reported
Diarrhea wk 12 chge (n=217,241)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib18.888Not reported15.0422.74Not reported
Placebo + Bortezomib10.206Not reported6.45213.96Not reported
Diarrhea wk 24 chge (n=150,177)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib23.163Not reported18.4627.87Not reported
Placebo + Bortezomib16.406Not reported11.9820.83Not reported
Diarrhea wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib20.48Not reported14.0226.94Not reported
Placebo + Bortezomib10.996Not reported3.42218.57Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.50
        upper Limit
        -7.20
        value
        -9.853
      2. group Id
        OG001
        lower Limit
        -6.60
        upper Limit
        -1.49
        value
        -4.044
    title
    Global health wk 12 change baseline (n=216,239)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.7
        upper Limit
        -5.08
        value
        -7.867
      2. group Id
        OG001
        lower Limit
        -4.11
        upper Limit
        -1.075
        value
        -1.518
    title
    Global health wk 24 change baseline (n=150,176)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.21
        upper Limit
        1.237
        value
        -2.986
      2. group Id
        OG001
        lower Limit
        -0.416
        upper Limit
        9.106
        value
        4.345
    title
    Global health wk 48 change baseline (n=38,26)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.00
        upper Limit
        -7.38
        value
        -9.67
      2. group Id
        OG001
        lower Limit
        -76.3
        upper Limit
        -3.16
        value
        -5.393
    title
    Physical functioning wk 12 chge (n=217,242)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.20
        upper Limit
        -7.38
        value
        -9.516
      2. group Id
        OG001
        lower Limit
        -8.98
        upper Limit
        -3.93
        value
        -6.456
    title
    Physical functioning wk 24 chge (n=151,177)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.41
        upper Limit
        0.651
        value
        -2.88
      2. group Id
        OG001
        lower Limit
        -2.07
        upper Limit
        6.147
        value
        2.037
    title
    Physical functioning wk 48 chge (n=38,26)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -14.6
        upper Limit
        -7.74
        value
        -11.159
      2. group Id
        OG001
        lower Limit
        -10.1
        upper Limit
        -3.45
        value
        -6.762
    title
    Role functioning wk 12 chge (n=215,237)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -15.7
        upper Limit
        -8.01
        value
        -11.875
      2. group Id
        OG001
        lower Limit
        -14.9
        upper Limit
        -7.61
        value
        -11.263
    title
    Role functioning wk 24 chge (n=150,176)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -11.4
        upper Limit
        -0.424
        value
        -5.927
      2. group Id
        OG001
        lower Limit
        -6.73
        upper Limit
        5.924
        value
        -0.401
    title
    Role functioning wk 48 chge (n=38,26)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.89
        upper Limit
        -2.04
        value
        -4.464
      2. group Id
        OG001
        lower Limit
        -3.36
        upper Limit
        1.318
        value
        -1.023
    title
    Cognitive functioning wk 12 chge (n=216,240)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.87
        upper Limit
        -3.24
        value
        -6.053
      2. group Id
        OG001
        lower Limit
        -6.22
        upper Limit
        -0.865
        value
        -3.542
    title
    Cognitive functioning wk 24 chge (n=149,176)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -9.79
        upper Limit
        -1.34
        value
        -5.568
      2. group Id
        OG001
        lower Limit
        -8.99
        upper Limit
        0.902
        value
        -4.042
    title
    Cognitive functioning wk 48 chge (n=38,26)
denoms
  1. counts
    1. group Id
      OG000
      value
      387
    2. group Id
      OG001
      value
      381
    units
    Participants
description
The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), six single-item symptom scales (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale. Disease Symptom is the sum of 30 questions, total score ranges from 0 (best possible outcome) to 100 (worst possible outcome)", All subscales of EORTC QLQ-C30 have the same score range of 0 -100. For global health status and other functional scales,an increase from baseline indicates improvement of QoL. Whereas for symptoms scales, fatigue, dyspnea, insomnia, appetite loss, constipation and diarrhea, decrease in 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-C30 - Summary Statistics by Treatment Group
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice