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NCT02000622 · OUTCOME

Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. · Source last updated 2026-02-13

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
95% Confidence Interval
Time frame
EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.

What was measured

Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.

Analysis population: Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment

Groups in this outcome

Olaparib 300 mg bd

Olaparib 300 mg bd tablets

Chemotherapy

Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin

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

Analysis denominator · Participants

GroupSource count
Olaparib 300 mg bd191
Chemotherapy73

Reported measurements

Source class 1
Values in Score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd3.9Not reported1.56.3Not reported
Chemotherapy-3.6Not reported-8.00.8Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.4
    estimate Comment
    Mean difference \>0 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0035
    param Type
    Mean Difference (Final Values)
    param Value
    7.5
    statistical Comment
    Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.4
    estimate Comment
    Mean difference \>0 favours olaparib.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0035
    param Type
    Mean Difference (Final Values)
    param Value
    7.5
    statistical Comment
    Variables for treatment, visit, treatment-visit interaction, adjusted for baseline global health status/QoL score, baseline score-visit interaction.
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.5
        upper Limit
        6.3
        value
        3.9
      2. group Id
        OG001
        lower Limit
        -8.0
        upper Limit
        0.8
        value
        -3.6
denoms
  1. counts
    1. group Id
      OG000
      value
      191
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Olaparib 300 mg bd tablets
    id
    OG000
    title
    Olaparib 300 mg bd
  2. description
    Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
    id
    OG001
    title
    Chemotherapy
param Type
MEAN
population Description
Subset of Full Analysis Set (FAS) consisting of all randomised patients with an evaluable baseline EORTC QLQ-C30 assessment and at least one evaluable post-baseline assessment
reporting Status
POSTED
time Frame
EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.
title
Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice