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NCT02290431 · OUTCOME

Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score

Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Japanese Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-18

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

Measure
MEDIAN
Unit
scores on a scale
Interval / dispersion
Full Range
Time frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156

What was measured

QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL.

Analysis population: FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.

Groups in this outcome

LBH589 + Bortezomib + Dexamethasone

Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.

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

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone31

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone31
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone112.33Not reported80.7144.5Not reported
Week 12

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone22
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone91.75Not reported65.7147.0Not reported
Week 24

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone17
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone100.33Not reported59.2149.0Not reported
Week 36

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone7
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone125.83Not reported91.0149.0Not reported
Week 48

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone6
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone114.25Not reported101.7145.0Not reported
Week 60

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone2
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone109.92Not reported82.5137.3Not reported
Week 72

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone1
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone108.00Not reported108.0108.0Not reported
Week 84

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone2
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone101.00Not reported92.0110.0Not reported
Week 96

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone3
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone121.67Not reported86.5133.0Not reported
Week 108

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone2
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone120.17Not reported117.0123.3Not reported
Week 120

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone2
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone125.25Not reported124.7125.8Not reported
Week 132

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone2
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone114.00Not reported109.3118.7Not reported
Week 156

Analysis denominator · Participants

GroupSource count
LBH589 + Bortezomib + Dexamethasone1
Values in scores on a scale · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
LBH589 + Bortezomib + Dexamethasone119.8Not reported119.8119.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.7
        upper Limit
        144.5
        value
        112.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.7
        upper Limit
        147.0
        value
        91.75
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Week 12
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.2
        upper Limit
        149.0
        value
        100.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        17
      units
      Participants
    title
    Week 24
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.0
        upper Limit
        149.0
        value
        125.83
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Week 36
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        101.7
        upper Limit
        145.0
        value
        114.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Week 48
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.5
        upper Limit
        137.3
        value
        109.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Week 60
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        108.0
        upper Limit
        108.0
        value
        108.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Week 72
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.0
        upper Limit
        110.0
        value
        101.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Week 84
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.5
        upper Limit
        133.0
        value
        121.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Week 96
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        117.0
        upper Limit
        123.3
        value
        120.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Week 108
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        124.7
        upper Limit
        125.8
        value
        125.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Week 120
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        109.3
        upper Limit
        118.7
        value
        114.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Week 132
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
QoL as measured by Functional Assessment of Cancer Therapy/ Gynecology Oncology Group Neurotoxicity (FACT/GOG-NTX) scale calculated scores and changes from baseline were summarized by visit. The FACT/GOG-Ntx is a measure to assess neurotoxicity from systemic chemotherapy. The recall period for this measure is the past 7 days. FACT/GOG-Ntx Total Score: 0 - 152 (28 + 28 + 24 + 28 + 44 = 152). (FACT-G Physical Well-Being Score: 0 - 28, FACT-G Social/Family Well-Being Score: 0 - 28, FACT-G Emotional Well-Being Score: 0 - 24, FACT-G Functional Well-Being Score: 0 - 28, FACT/GOG-Ntx Neurotoxicity Subscale Score: 0 - 44). 4. The scales are combined. The higher the score, the better the QOL.
dispersion Type
Full Range
groups
  1. description
    Participants were administered LBH589 (panobinostat)in combination with bortezomib and dexamethasone 2 weeks on/1 week off.
    id
    OG000
    title
    LBH589 + Bortezomib + Dexamethasone
param Type
MEDIAN
population Description
FAS: The FAS comprised of all subjects who took at least one dose of any study treatment component.
reporting Status
POSTED
time Frame
Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, and 156
title
Quality of Life (QoL) as Measured by FACT/GOG-Ntx Total Score
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice