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NCT02032823 · OUTCOME

Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy

Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer · Source last updated 2026-07-14

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

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
95% Confidence Interval
Time frame
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)

What was measured

Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.

Analysis population: Patient reported outcomes (PRO) Analysis Set

Groups in this outcome

Olaparib

Olaparib tablets 300mg taken orally twice daily.

Placebo

Placebo tablets taken orally twice daily.

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

Analysis denominator · Participants

GroupSource count
Olaparib382
Placebo359

Reported measurements

Change from baseline FACIT-Fatigue Score to 6 months

Analysis denominator · Participants

GroupSource count
Olaparib382
Placebo359
Values in Scores on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib-1.5Not reported-2.3-0.8Not reported
Placebo-0.2Not reported-1.00.6Not reported
Change from baseline FACIT-Fatigue Score to 12 months

Analysis denominator · Participants

GroupSource count
Olaparib382
Placebo356
Values in Scores on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib-1.5Not reported-2.4-0.6Not reported
Placebo0.0Not reported-0.90.9Not reported
Change from baseline FACIT-Fatigue Score to 18 months

Analysis denominator · Participants

GroupSource count
Olaparib382
Placebo359
Values in Scores on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib1.3Not reported0.42.2Not reported
Placebo1.4Not reported0.52.3Not reported
Change from baseline FACIT-Fatigue Score to 24 months

Analysis denominator · Participants

GroupSource count
Olaparib382
Placebo359
Values in Scores on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib1.6Not reported0.72.4Not reported
Placebo2.0Not reported1.12.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.3
        upper Limit
        -0.8
        value
        -1.5
      2. group Id
        OG001
        lower Limit
        -1.0
        upper Limit
        0.6
        value
        -0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        359
      units
      Participants
    title
    Change from baseline FACIT-Fatigue Score to 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.4
        upper Limit
        -0.6
        value
        -1.5
      2. group Id
        OG001
        lower Limit
        -0.9
        upper Limit
        0.9
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        356
      units
      Participants
    title
    Change from baseline FACIT-Fatigue Score to 12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.4
        upper Limit
        2.2
        value
        1.3
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        2.3
        value
        1.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        359
      units
      Participants
    title
    Change from baseline FACIT-Fatigue Score to 18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        2.4
        value
        1.6
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        2.9
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        382
      2. group Id
        OG001
        value
        359
      units
      Participants
    title
    Change from baseline FACIT-Fatigue Score to 24 months
denoms
  1. counts
    1. group Id
      OG000
      value
      382
    2. group Id
      OG001
      value
      359
    units
    Participants
description
Change from baseline for FACIT-Fatigue Score at 6, 12, 18 and 24 months for patients who completed neoadjuvant chemotherapy. Adjusted least-square mean changes and 95% Confidence Interval (CI) are obtained from mixed model for repeated measures (MMRM) analysis of the change from baseline. Only patients with evaluable baseline forms are included. FACIT-Fatigue score ranges from 0 to 52 with higher score indicating less fatigue.
dispersion Type
95% Confidence Interval
groups
  1. description
    Olaparib tablets 300mg taken orally twice daily.
    id
    OG000
    title
    Olaparib
  2. description
    Placebo tablets taken orally twice daily.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Patient reported outcomes (PRO) Analysis Set
reporting Status
POSTED
time Frame
6, 12, 18 and 24 months after randomisation (data cut off: 12 July 2021)
title
Change From Baseline for FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) Score for Participants Who Completed Neoadjuvant Chemotherapy
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice