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NCT00555906 · OUTCOME

Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)

What was measured

m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 "No pain" to 10 "Pain as bad as you can imagine". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.

Analysis population: The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.

Groups in this outcome

Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)

Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)26

Reported measurements

C1D1: Pain Severity (n=26)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.32Not reported1.43.2Not reported
C1D8: Pain Severity (n=25)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.62Not reported1.73.6Not reported
C1D15: Pain Severity (n=24)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.44Not reported1.53.4Not reported
C2D1: Pain Severity (n=24)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.30Not reported1.53.2Not reported
C3D1: Pain Severity (n=21)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.12Not reported1.23.1Not reported
C4D1: Pain Severity (n=17)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.02Not reported0.93.1Not reported
C5D1: Pain Severity (n=16)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.22Not reported1.03.4Not reported
C6D1: Pain Severity (n=14)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.66Not reported0.72.6Not reported
C7D1: Pain Severity (n=10)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.98Not reported0.53.5Not reported
C8D1: Pain Severity (n=9)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.47Not reported0.64.4Not reported
C9D1: Pain Severity (n=9)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.81Not reported0.53.1Not reported
C10D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.08Not reported-0.12.3Not reported
C11D1: Pain Severity (n=5)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.45Not reported-0.02.9Not reported
C12D1: Pain Severity (n=5)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.67Not reported0.42.9Not reported
C13D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)0.93Not reported0.11.7Not reported
C14D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.42Not reported0.12.7Not reported
C15D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.04Not reported-0.02.1Not reported
C16D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.46Not reported0.02.9Not reported
C17D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.67Not reported-0.33.6Not reported
C18D1: Pain Severity (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.88Not reported1.14.7Not reported
C19D1: Pain Severity (n=4)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)3.69Not reported1.36.1Not reported
C20D1: Pain Severity (n=2)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)3.50Not reported0.36.7Not reported
C21D1: Pain Severity (n=1)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)4.00Not reportedNANA95% CI was not estimable since only 1 participant was evaluable.
C22D1: Pain Severity (n=1)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)4.50Not reportedNANA95% CI was not estimable since only 1 participant was evaluable.
End of Treatment: Pain Severity (n=16)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)3.30Not reported1.94.6Not reported
C1D1: Pain Interference (n=25)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.53Not reported1.43.6Not reported
C1D8: Pain Interference (n=25)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.58Not reported1.43.7Not reported
C1D15: Pain Interference (n=23)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)3.06Not reported1.94.3Not reported
C2D1: Pain Interference (n=23)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.64Not reported1.53.7Not reported
C3D1: Pain Interference (n=21)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.34Not reported1.13.5Not reported
C4D1: Pain Interference (n=17)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.54Not reported1.23.9Not reported
C5D1: Pain Interference (n=16)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.74Not reported1.34.2Not reported
C6D1: Pain Interference (n=14)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.26Not reported0.83.7Not reported
C7D1: Pain Interference (n=10)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.94Not reported0.65.3Not reported
C8D1: Pain Interference (n=9)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.60Not reported0.64.6Not reported
C9D1: Pain Interference (n=9)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.13Not reported-0.04.3Not reported
C10D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.07Not reported-0.14.2Not reported
C11D1: Pain Interference (n=5)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.40Not reported1.13.7Not reported
C12D1: Pain Interference (n=5)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.91Not reported1.04.8Not reported
C13D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.90Not reported0.33.5Not reported
C14D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)0.98Not reported-0.12.1Not reported
C15D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.31Not reported0.22.4Not reported
C16D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.83Not reported0.43.3Not reported
C17D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)1.50Not reported0.42.6Not reported
C18D1: Pain Interference (n=6)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.86Not reported0.94.9Not reported
C19D1: Pain Interference (n=4)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)4.07Not reported2.16.0Not reported
C20D1: Pain Interference (n=2)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)5.07Not reported-14.024.1Not reported
C21D1: Pain Interference (n=1)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)2.57Not reportedNANA95% CI was not estimable since only 1 participant was evaluable.
C22D1: Pain Interference (n=1)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)6.71Not reportedNANA95% CI was not estimable since only 1 participant was evaluable.
End of Treatment: Pain Interference (n=16)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)3.46Not reported1.95.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        3.2
        value
        2.32
    title
    C1D1: Pain Severity (n=26)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        3.6
        value
        2.62
    title
    C1D8: Pain Severity (n=25)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        3.4
        value
        2.44
    title
    C1D15: Pain Severity (n=24)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        3.2
        value
        2.30
    title
    C2D1: Pain Severity (n=24)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        3.1
        value
        2.12
    title
    C3D1: Pain Severity (n=21)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        3.1
        value
        2.02
    title
    C4D1: Pain Severity (n=17)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        3.4
        value
        2.22
    title
    C5D1: Pain Severity (n=16)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        2.6
        value
        1.66
    title
    C6D1: Pain Severity (n=14)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3.5
        value
        1.98
    title
    C7D1: Pain Severity (n=10)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        4.4
        value
        2.47
    title
    C8D1: Pain Severity (n=9)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.5
        upper Limit
        3.1
        value
        1.81
    title
    C9D1: Pain Severity (n=9)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.1
        upper Limit
        2.3
        value
        1.08
    title
    C10D1: Pain Severity (n=6)
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
m-BPI-sf was a questionnaire designed to assess the severity of pain and the impact of pain on daily functions. m-BPI-sf contained questions that assessed pain severity (worst, least, average, right now) and pain interference (general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life). Each question was answered on a scale ranging from 0 "No pain" to 10 "Pain as bad as you can imagine". The 4 pain severity questions were averaged to derive an index of pain severity and the 7 function questions were averaged to derive an index for pain interference. Total score range for pain severity and interference indices: 0 to 10, where higher score indicated higher severity/interference.
dispersion Type
95% Confidence Interval
groups
  1. description
    Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    OG000
    title
    Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)
param Type
MEAN
population Description
The PRO analysis set included all enrolled participants who received study treatment, had a baseline PRO assessment, and completed at least 1 on-study PRO assessment.'N' signifies those participants who were evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively.
reporting Status
POSTED
time Frame
C1D1 (baseline), C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1, C12D1, C13D1, C14D1, C15D1, C16D1, C17D1, C18D1, C19D1, C20D1, C21D1, C22D1, End of Treatment (assessment at early withdrawal occurring up to Cycle 22)
title
Modified Version of Brief Pain Inventory - Short Form (m-BPI-sf) Questionnaire: Phase 2
type
SECONDARY
unit Of Measure
units on a scale

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