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NCT02278120 · OUTCOME

Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer · Source last updated 2024-03-12

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

Measure
MEAN
Unit
Score on a Scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days

What was measured

The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.

Analysis population: Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.

Groups in this outcome

Ribociclib + NSAI/Tamoxifen + Goserelin

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)

Placebo + NSAI/Tamoxifen+ Goserelin

Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).

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

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin300
Placebo + NSAI/Tamoxifen+ Goserelin280

Reported measurements

Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin300
Placebo + NSAI/Tamoxifen+ Goserelin280
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.621.64Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin5.022.10Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin277
Placebo + NSAI/Tamoxifen+ Goserelin246
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5.121.81Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin5.120.60Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin263
Placebo + NSAI/Tamoxifen+ Goserelin231
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5.021.67Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin4.022.57Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin250
Placebo + NSAI/Tamoxifen+ Goserelin207
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.822.37Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin3.723.76Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin236
Placebo + NSAI/Tamoxifen+ Goserelin185
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.322.17Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin4.424.53Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin213
Placebo + NSAI/Tamoxifen+ Goserelin166
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.721.14Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin3.925.19Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin204
Placebo + NSAI/Tamoxifen+ Goserelin150
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.822.44Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin3.224.91Not reportedNot reportedNot reported
Cycle 17 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin170
Placebo + NSAI/Tamoxifen+ Goserelin117
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin4.020.60Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin2.725.68Not reportedNot reportedNot reported
Cycle 19 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin128
Placebo + NSAI/Tamoxifen+ Goserelin85
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5.522.12Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-1.224.10Not reportedNot reportedNot reported
Cycle 22 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin79
Placebo + NSAI/Tamoxifen+ Goserelin46
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin7.625.43Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-3.425.43Not reportedNot reportedNot reported
Cycle 25 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin50
Placebo + NSAI/Tamoxifen+ Goserelin25
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5.219.41Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-0.325.51Not reportedNot reportedNot reported
Cycle 28 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin19
Placebo + NSAI/Tamoxifen+ Goserelin11
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin7.919.54Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-8.330.28Not reportedNot reportedNot reported
Cycle 31 Day 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin2
Placebo + NSAI/Tamoxifen+ Goserelin1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin8.311.79Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-8.3Not reportedNot reportedNot reportedNot reported
End of treatment

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin129
Placebo + NSAI/Tamoxifen+ Goserelin179
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin-4.427.78Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-3.023.41Not reportedNot reportedNot reported
Post-end of treatment 1

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin9
Placebo + NSAI/Tamoxifen+ Goserelin11
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin3.725.38Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin6.832.02Not reportedNot reportedNot reported
Post-end of treatment 2

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin3
Placebo + NSAI/Tamoxifen+ Goserelin2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin5.612.73Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin0.011.79Not reportedNot reportedNot reported
Post-end of treatment 3

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin3
Placebo + NSAI/Tamoxifen+ Goserelin2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin8.314.43Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-4.25.89Not reportedNot reportedNot reported
Post-end of treatment 4

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin3
Placebo + NSAI/Tamoxifen+ Goserelin1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin11.117.35Not reportedNot reportedNot reported
Placebo + NSAI/Tamoxifen+ Goserelin-8.3Not reportedNot reportedNot reportedNot reported
Post-end of treatment 5

Analysis denominator · Participants

GroupSource count
Ribociclib + NSAI/Tamoxifen + Goserelin1
Placebo + NSAI/Tamoxifen+ Goserelin0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ribociclib + NSAI/Tamoxifen + Goserelin16.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.64
        value
        4.6
      2. group Id
        OG001
        spread
        22.10
        value
        5.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        300
      2. group Id
        OG001
        value
        280
      units
      Participants
    title
    Cycle 3 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.81
        value
        5.1
      2. group Id
        OG001
        spread
        20.60
        value
        5.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        277
      2. group Id
        OG001
        value
        246
      units
      Participants
    title
    Cycle 5 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.67
        value
        5.0
      2. group Id
        OG001
        spread
        22.57
        value
        4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        263
      2. group Id
        OG001
        value
        231
      units
      Participants
    title
    Cycle 7 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.37
        value
        4.8
      2. group Id
        OG001
        spread
        23.76
        value
        3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        250
      2. group Id
        OG001
        value
        207
      units
      Participants
    title
    Cycle 9 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.17
        value
        4.3
      2. group Id
        OG001
        spread
        24.53
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        236
      2. group Id
        OG001
        value
        185
      units
      Participants
    title
    Cycle 11 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.14
        value
        4.7
      2. group Id
        OG001
        spread
        25.19
        value
        3.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        213
      2. group Id
        OG001
        value
        166
      units
      Participants
    title
    Cycle 13 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.44
        value
        4.8
      2. group Id
        OG001
        spread
        24.91
        value
        3.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        150
      units
      Participants
    title
    Cycle 15 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.60
        value
        4.0
      2. group Id
        OG001
        spread
        25.68
        value
        2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        170
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Cycle 17 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.12
        value
        5.5
      2. group Id
        OG001
        spread
        24.10
        value
        -1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        85
      units
      Participants
    title
    Cycle 19 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.43
        value
        7.6
      2. group Id
        OG001
        spread
        25.43
        value
        -3.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        46
      units
      Participants
    title
    Cycle 22 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.41
        value
        5.2
      2. group Id
        OG001
        spread
        25.51
        value
        -0.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        25
      units
      Participants
    title
    Cycle 25 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.54
        value
        7.9
      2. group Id
        OG001
        spread
        30.28
        value
        -8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Cycle 28 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      300
    2. group Id
      OG001
      value
      280
    units
    Participants
description
The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.
dispersion Type
Standard Deviation
groups
  1. description
    Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
    id
    OG000
    title
    Ribociclib + NSAI/Tamoxifen + Goserelin
  2. description
    Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days).
    id
    OG001
    title
    Placebo + NSAI/Tamoxifen+ Goserelin
param Type
MEAN
population Description
Randomized participants with data available at the specified time points. Number analyzed refers to the number of participants with an evaluable value at the specified time point.
reporting Status
POSTED
time Frame
Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days
title
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
type
SECONDARY
unit Of Measure
Score on a Scale

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