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NCT01844986 · OUTCOME

Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy. · Source last updated 2025-12-10

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018

What was measured

To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.

Analysis population: Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).

Groups in this outcome

Olaparib 300mg Tablets (Global Cohort)

Taken orally twice daily

Placebo Tablets (Global Cohort)

Taken orally twice daily

Olaparib 300mg Tablets (China Cohort)

Taken orally twice daily

Placebo Tablets (China 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)260
Placebo Tablets (Global Cohort)131
Olaparib 300mg Tablets (China Cohort)44
Placebo Tablets (China Cohort)20

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets (Global Cohort)NANot reportedNANAInsufficient PFS events to estimate median, lower and upper confidence limit.
Placebo Tablets (Global Cohort)13.8Not reported11.118.2Not reported
Olaparib 300mg Tablets (China Cohort)NANot reportedNANAInsufficient PFS events to estimate median, lower and upper confidence limit.
Placebo Tablets (China Cohort)9.3Not reported6.4NAInsufficient PFS events to estimate upper confidence limit.

Source statistical analyses

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

  1. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.41
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Determined using a log-rank test stratified by response to previous platinum chemotherapy
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    Model includes a factor for response to previous platinum chemotherapy
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value Comment
    Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
    param Type
    Hazard Ratio (HR)
    param Value
    0.46
    statistical Comment
    Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.41
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Determined using a log-rank test stratified by response to previous platinum chemotherapy
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    Model includes a factor for response to previous platinum chemotherapy
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.23
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY
    p Value Comment
    Not applicable, due to small sample size. China cohort designed to provide descriptive analysis only.
    param Type
    Hazard Ratio (HR)
    param Value
    0.46
    statistical Comment
    Model includes the stratification variable of response to first-line platinum chemotherapy as a covariate.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. comment
        Insufficient PFS events to estimate median, lower and upper confidence limit.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        18.2
        value
        13.8
      3. comment
        Insufficient PFS events to estimate median, lower and upper confidence limit.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Insufficient PFS events to estimate upper confidence limit.
        group Id
        OG003
        lower Limit
        6.4
        upper Limit
        NA
        value
        9.3
denoms
  1. counts
    1. group Id
      OG000
      value
      260
    2. group Id
      OG001
      value
      131
    3. group Id
      OG002
      value
      44
    4. group Id
      OG003
      value
      20
    units
    Participants
description
To determine the efficacy by progression free survival (PFS) using investigator assessment according to modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) of olaparib maintenance monotherapy compared to placebo in BRCA mutated high risk advanced ovarian cancer patients who are in clinical complete response or partial response following first line platinum based chemotherapy.
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)
  3. description
    Taken orally twice daily
    id
    OG002
    title
    Olaparib 300mg Tablets (China Cohort)
  4. description
    Taken orally twice daily
    id
    OG003
    title
    Placebo Tablets (China Cohort)
param Type
MEDIAN
population Description
Global Full Analysis Set (FAS) consisting of all patients randomized as part of global recruitment (including 5 patients randomized in China) \[Primary analysis\] China Full Analysis Set (FAS) consisting of all patients randomized at sites in China (including 5 patients also included in the Global Cohort).
reporting Status
POSTED
time Frame
Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018
title
Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice