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NCT01023308 · OUTCOME

Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-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

Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.

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

Neurotoxicity wk 12 change baseline (n=212,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-4.481Not reported-5.33-3.63Not reported
Placebo + Bortezomib-3.337Not reported-4.17-2.50Not reported
Neurotoxicity wk 24 change baseline (n=148,174)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-4.564Not reported-5.49-3.64Not reported
Placebo + Bortezomib-4.739Not reported-5.61-3.86Not reported
Neurotoxicity wk 48 change baseline (n=35,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-3.158Not reported-4.52-1.79Not reported
Placebo + Bortezomib-2.133Not reported-3.64-0.627Not reported
Physical wellbeing wk 12 chge (n=215,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-3.29Not reported-3.94-2.64Not reported
Placebo + Bortezomib-1.952Not reported-2.58-1.32Not reported
Physical wellbeingwk 24 chge (n=150,176)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-3.044Not reported-3.74-2.35Not reported
Placebo + Bortezomib-2.259Not reported-2.92-1.60Not reported
Physical wellbeing wk 48 chge (n=38,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.037Not reported-3.08-0.992Not reported
Placebo + Bortezomib0.203Not reported-1.031.439Not reported
Trial Outcomes wk 12 chge (n=209,236)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-10.573Not reported-12.2-8.86Not reported
Placebo + Bortezomib-6.874Not reported-8.55-5.19Not reported
Trial Outcomes wk 24 chge (n=148,173)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-9.84Not reported-11.7-7.98Not reported
Placebo + Bortezomib-8.894Not reported-10.7-7.13Not reported
Trial Outcomes wk 48 chge (n=35,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-6.633Not reported-9.28-3.98Not reported
Placebo + Bortezomib-2.821Not reported-5.760.122Not reported
FACT-G Total wk 12 chge (n=213,240)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-6.658Not reported-8.23-5.09Not reported
Placebo + Bortezomib-4.106Not reported-5.64-2.57Not reported
FACT-G Totalwk 24 chge (n=147,175)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-6.076Not reported-7.84-4.31Not reported
Placebo + Bortezomib-4.609Not reported-6.30-2.92Not reported
FACT-G Total wk 48 chge (n=37,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-2.704Not reported-5.29-0.118Not reported
Placebo + Bortezomib-1.435Not reported-4.421.547Not reported
FACT/GOGNTX Total wk 12 chge (n=206,230)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-11.176Not reported-13.3-9.03Not reported
Placebo + Bortezomib-7.524Not reported-9.64-5.41Not reported
FACT/GOGNTX Total wk 24 chge (n=146,172)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-10.581Not reported-12.9-8.23Not reported
Placebo + Bortezomib-9.179Not reported-9.64-5.41Not reported
FACT/GOGNTX Total wk 48 chge (n=35,26)
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Panobinostat + Bortezomib-5.871Not reported-9.24-2.50Not reported
Placebo + Bortezomib-3.151Not reported-6.920.614Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.33
        upper Limit
        -3.63
        value
        -4.481
      2. group Id
        OG001
        lower Limit
        -4.17
        upper Limit
        -2.50
        value
        -3.337
    title
    Neurotoxicity wk 12 change baseline (n=212,240)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.49
        upper Limit
        -3.64
        value
        -4.564
      2. group Id
        OG001
        lower Limit
        -5.61
        upper Limit
        -3.86
        value
        -4.739
    title
    Neurotoxicity wk 24 change baseline (n=148,174)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.52
        upper Limit
        -1.79
        value
        -3.158
      2. group Id
        OG001
        lower Limit
        -3.64
        upper Limit
        -0.627
        value
        -2.133
    title
    Neurotoxicity wk 48 change baseline (n=35,26)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.94
        upper Limit
        -2.64
        value
        -3.29
      2. group Id
        OG001
        lower Limit
        -2.58
        upper Limit
        -1.32
        value
        -1.952
    title
    Physical wellbeing wk 12 chge (n=215,240)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.74
        upper Limit
        -2.35
        value
        -3.044
      2. group Id
        OG001
        lower Limit
        -2.92
        upper Limit
        -1.60
        value
        -2.259
    title
    Physical wellbeingwk 24 chge (n=150,176)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -3.08
        upper Limit
        -0.992
        value
        -2.037
      2. group Id
        OG001
        lower Limit
        -1.03
        upper Limit
        1.439
        value
        0.203
    title
    Physical wellbeing wk 48 chge (n=38,26)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.2
        upper Limit
        -8.86
        value
        -10.573
      2. group Id
        OG001
        lower Limit
        -8.55
        upper Limit
        -5.19
        value
        -6.874
    title
    Trial Outcomes wk 12 chge (n=209,236)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -11.7
        upper Limit
        -7.98
        value
        -9.84
      2. group Id
        OG001
        lower Limit
        -10.7
        upper Limit
        -7.13
        value
        -8.894
    title
    Trial Outcomes wk 24 chge (n=148,173)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -9.28
        upper Limit
        -3.98
        value
        -6.633
      2. group Id
        OG001
        lower Limit
        -5.76
        upper Limit
        0.122
        value
        -2.821
    title
    Trial Outcomes wk 48 chge (n=35,26)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.23
        upper Limit
        -5.09
        value
        -6.658
      2. group Id
        OG001
        lower Limit
        -5.64
        upper Limit
        -2.57
        value
        -4.106
    title
    FACT-G Total wk 12 chge (n=213,240)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.84
        upper Limit
        -4.31
        value
        -6.076
      2. group Id
        OG001
        lower Limit
        -6.30
        upper Limit
        -2.92
        value
        -4.609
    title
    FACT-G Totalwk 24 chge (n=147,175)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.29
        upper Limit
        -0.118
        value
        -2.704
      2. group Id
        OG001
        lower Limit
        -4.42
        upper Limit
        1.547
        value
        -1.435
    title
    FACT-G Total wk 48 chge (n=37,26)
denoms
  1. counts
    1. group Id
      OG000
      value
      387
    2. group Id
      OG001
      value
      381
    units
    Participants
description
Chronic Illness Therapy (FACIT) Measurement System and focuses on four general quality of life domains for physical well being, functional well-being, social/family well-being, and emotional well-being, and includes additional items to characterize treatment-related neurotoxicity. Higher subscales/total scores represent higher QOL. In the case of the neurotoxicity subscale, lower scores correspond to higher neurotoxicity. The recall period referenced in the questionnaire is the past 7 days.Ranges for FACT-G subscales are as follows:.PWB, scale 0 -28, , NtxS scale 0-44, FACT/GOG-Ntx trial outcome index scale is 0-100 and FACT-G scale is also scaled 0-100. An increase from baseline in these scores indicate improvement.
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
Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System : FACT/GOG-NTX-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