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NCT01874353 · OUTCOME

Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)

Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy · Source last updated 2026-07-29

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

Measure
LEAST_SQUARES_MEAN
Unit
Change in TOI over 12 months
Interval / dispersion
95% Confidence Interval
Time frame
Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.

What was measured

To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.

Analysis population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available \[This endpoint was not assessed in the China Cohort\]

Groups in this outcome

Olaparib 300mg Tablets (Global Cohort)

Taken orally twice daily

Placebo Tablets (Global Cohort)

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
Olaparib 300mg Tablets (Global Cohort)185
Placebo Tablets (Global Cohort)94

Reported measurements

Source class 1
Values in Change in TOI over 12 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets (Global Cohort)-2.90Not reported-4.131-1.673Not reported
Placebo Tablets (Global Cohort)-2.87Not reported-4.643-1.097Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -2.191
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.126
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9765
    param Type
    Mean Difference (Final Values)
    param Value
    -0.03
    statistical Comment
    Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -2.191
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.126
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9765
    param Type
    Mean Difference (Final Values)
    param Value
    -0.03
    statistical Comment
    Fixed effects for treatment, visit and baseline TOI with the treatment by visit and baseline TOI by visit interaction. Random patient effect.
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.131
        upper Limit
        -1.673
        value
        -2.90
      2. group Id
        OG001
        lower Limit
        -4.643
        upper Limit
        -1.097
        value
        -2.87
denoms
  1. counts
    1. group Id
      OG000
      value
      185
    2. group Id
      OG001
      value
      94
    units
    Participants
description
To compare the effects of olaparib maintenance monotherapy compared to placebo on Health-related Quality of Life (HRQoL) as assessed by the trial outcome index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O) in BRCA mutated relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy. The TOI ranges from 0-100 and a higher score indicates a higher HRQoL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Taken orally twice daily
    id
    OG000
    title
    Olaparib 300mg Tablets (Global Cohort)
  2. description
    Taken orally twice daily
    id
    OG001
    title
    Placebo Tablets (Global Cohort)
param Type
LEAST_SQUARES_MEAN
population Description
Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) with a baseline and post baseline TOI score available \[This endpoint was not assessed in the China Cohort\]
reporting Status
POSTED
time Frame
Questionnaires completed by patient at baseline, Day 29 and then every 12 weeks for 12 months. Assessed until 19 Sep 2016 DCO.
title
Change From Baseline in Health-Related Quality of Life (HRQoL) as Assessed by the the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian (FACT-O)
type
SECONDARY
unit Of Measure
Change in TOI over 12 months

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

Preserved source evidence · Not medical advice