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NCT01874353 · OUTCOME

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

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.

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 relapsed ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.

Analysis population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment, excluding China \[Primary analysis\] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.

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)196
Placebo Tablets (Global Cohort)99
Olaparib 300mg Tablets (China Cohort)22
Placebo Tablets (China Cohort)10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets (Global Cohort)19.1Not reported16.325.7Not reported
Placebo Tablets (Global Cohort)5.5Not reported5.25.8Not reported
Olaparib 300mg Tablets (China Cohort)13.8Not reported6.516.6Not reported
Placebo Tablets (China Cohort)5.5Not reported2.7NAInsufficient PFS events to estimate upper 95% CI

Source statistical analyses

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

  1. ci Lower Limit
    0.22
    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_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    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
    0.44
    statistical Comment
    Model includes a treatment factor only
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.22
    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_OR_OTHER_LEGACY
    p Value
    <0.0001
    p Value Comment
    Determined using a log-rank test stratified by response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy prior to enrolment
    param Type
    Hazard Ratio (HR)
    param Value
    0.30
    statistical Comment
    Model includes factors for response to previous platinum chemotherapy and time to disease progression in the penultimate platinum based chemotherapy
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.17
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    A hazard ratio \< 1 favours olaparib
    group Ids
    1. OG002
    2. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    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
    0.44
    statistical Comment
    Model includes a treatment factor only
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.3
        upper Limit
        25.7
        value
        19.1
      2. group Id
        OG001
        lower Limit
        5.2
        upper Limit
        5.8
        value
        5.5
      3. group Id
        OG002
        lower Limit
        6.5
        upper Limit
        16.6
        value
        13.8
      4. comment
        Insufficient PFS events to estimate upper 95% CI
        group Id
        OG003
        lower Limit
        2.7
        upper Limit
        NA
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      99
    3. group Id
      OG002
      value
      22
    4. group Id
      OG003
      value
      10
    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 relapsed ovarian cancer patients who are in complete or partial response following 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
Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment, excluding China \[Primary analysis\] China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.
reporting Status
POSTED
time Frame
Radiologic scans performed at baseline then every ~12 weeks up to 72 weeks, then every ~ 24 weeks thereafter until objective radiological disease progression. Assessed until 19 Sep 2016 DCO (16 Jan 2017 DCO for China Cohort); up to a maximum of 36 months.
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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