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NCT01611090 · OUTCOME

Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment

A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma · Source last updated 2020-03-03

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

Measure
MEAN
Unit
Units on the scale
Interval / dispersion
Standard Deviation
Time frame
Baseline to EOT (up to 2 years)

What was measured

The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much).

Analysis population: ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. Here, 'n' signifies the number of participants analyzed for the specified symptoms.

Groups in this outcome

Ibrutinib+BR

Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.

Placebo+BR

Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104

Reported measurements

Lost weight

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.10.86Not reportedNot reportedNot reported
Placebo+BR0.00.74Not reportedNot reportedNot reported
Dry mouth

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.30.96Not reportedNot reportedNot reported
Placebo+BR0.10.85Not reportedNot reportedNot reported
Bruises

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.10.61Not reportedNot reportedNot reported
Placebo+BR0.00.65Not reportedNot reportedNot reported
Abdominal discomfort

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR37
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.10.81Not reportedNot reportedNot reported
Placebo+BR0.00.76Not reportedNot reportedNot reported
Temperature going up and down

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.10.93Not reportedNot reportedNot reported
Placebo+BR0.00.72Not reportedNot reportedNot reported
Night sweats

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR103
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR-0.60.92Not reportedNot reportedNot reported
Placebo+BR-0.31.07Not reportedNot reportedNot reported
Skin problems

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR37
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.41.14Not reportedNot reportedNot reported
Placebo+BR0.30.96Not reportedNot reportedNot reported
Feel ill

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.11.08Not reportedNot reportedNot reported
Placebo+BR0.20.98Not reportedNot reportedNot reported
Feel lethargic

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.11.01Not reportedNot reportedNot reported
Placebo+BR0.00.91Not reportedNot reportedNot reported
Felt slowed down

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR103
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.30.80Not reportedNot reportedNot reported
Placebo+BR0.00.97Not reportedNot reportedNot reported
Limited in planning activities

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR103
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.20.97Not reportedNot reportedNot reported
Placebo+BR0.10.90Not reportedNot reportedNot reported
Worried about health in the future

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR103
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.00.94Not reportedNot reportedNot reported
Placebo+BR0.00.97Not reportedNot reportedNot reported
Trouble with chest infections

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.21.05Not reportedNot reportedNot reported
Placebo+BR0.00.82Not reportedNot reportedNot reported
Trouble with other infections

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.71.07Not reportedNot reportedNot reported
Placebo+BR0.10.86Not reportedNot reportedNot reported
Repeated courses of antibiotics

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR104
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.91.22Not reportedNot reportedNot reported
Placebo+BR0.00.97Not reportedNot reportedNot reported
Worried about picking up infection

Analysis denominator · Participants

GroupSource count
Ibrutinib+BR38
Placebo+BR103
Values in Units on the scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ibrutinib+BR0.30.96Not reportedNot reportedNot reported
Placebo+BR0.21.00Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.86
        value
        0.1
      2. group Id
        OG001
        spread
        0.74
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Lost weight
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.96
        value
        0.3
      2. group Id
        OG001
        spread
        0.85
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Dry mouth
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.61
        value
        0.1
      2. group Id
        OG001
        spread
        0.65
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Bruises
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.81
        value
        0.1
      2. group Id
        OG001
        spread
        0.76
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Abdominal discomfort
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.93
        value
        0.1
      2. group Id
        OG001
        spread
        0.72
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Temperature going up and down
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.92
        value
        -0.6
      2. group Id
        OG001
        spread
        1.07
        value
        -0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        103
      units
      Participants
    title
    Night sweats
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.14
        value
        0.4
      2. group Id
        OG001
        spread
        0.96
        value
        0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Skin problems
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.08
        value
        0.1
      2. group Id
        OG001
        spread
        0.98
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Feel ill
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.01
        value
        0.1
      2. group Id
        OG001
        spread
        0.91
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Feel lethargic
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.80
        value
        0.3
      2. group Id
        OG001
        spread
        0.97
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        103
      units
      Participants
    title
    Felt slowed down
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.97
        value
        0.2
      2. group Id
        OG001
        spread
        0.90
        value
        0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        103
      units
      Participants
    title
    Limited in planning activities
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.94
        value
        0.0
      2. group Id
        OG001
        spread
        0.97
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        103
      units
      Participants
    title
    Worried about health in the future
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      104
    units
    Participants
description
The EORTC QLQ-CLL 16 is a 16-item disease specific module that comprises 5 domains of patient-reported health status important in CLL. There are three multi-item scales that include fatigue (2 items), treatment side effects and disease symptoms (8 items), and infection (4 items), and 2 single-item scales on social activities and future health worries. Responses are measured on a 4 point scale ranging from 1 (not at all) to 4 (very much).
dispersion Type
Standard Deviation
groups
  1. description
    Participants received ibrutinib 420 milligram (mg) (3 \* 140 mg capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles ibrutinib alone was administered until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Ibrutinib+BR
  2. description
    Participants received placebo (3 capsules) orally once daily starting on Cycle 1 Day 2 for a maximum of 6 cycles (each cycle of 28 days except Cycle 1 which was of 29 days) along with BR. After 6 cycles placebo alone was administered until disease progression or unacceptable toxicity.
    id
    OG001
    title
    Placebo+BR
param Type
MEAN
population Description
ITT population included all participants randomized into the study regardless of treatment actually received. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this endpoint. Here, 'n' signifies the number of participants analyzed for the specified symptoms.
reporting Status
POSTED
time Frame
Baseline to EOT (up to 2 years)
title
Change From Baseline in EORTC QLQ-CLL 16 Domain Scores at End of Treatment
type
SECONDARY
unit Of Measure
Units on the scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice