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NCT01874353 · OUTCOME

Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.

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 for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.

What was measured

To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

Analysis population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm \[This endpoint was not assessed in the China Cohort\]

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)190
Placebo Tablets (Global Cohort)96

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300mg Tablets (Global Cohort)19.3Not reported16.527.3Not reported
Placebo Tablets (Global Cohort)5.5Not reported5.05.8Not reported

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
    0.40
    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
Complete source fields
analyses
  1. ci Lower Limit
    0.22
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.40
    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
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.5
        upper Limit
        27.3
        value
        19.3
      2. group Id
        OG001
        lower Limit
        5.0
        upper Limit
        5.8
        value
        5.5
denoms
  1. counts
    1. group Id
      OG000
      value
      190
    2. group Id
      OG001
      value
      96
    units
    Participants
description
To assess efficacy of olaparib in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).
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
MEDIAN
population Description
Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China) and confirmed as Myriad gBRCAm \[This endpoint was not assessed in the China Cohort\]
reporting Status
POSTED
time Frame
Radiologic scans performed at baseline then every ~12 weeks for the first 72 weeks, then every ~24 weeks thereafter, assessed until disease progression. Assessed until 19 Sep 2016 DCO.
title
Efficacy in Patients With a Deleterious or Suspected Deleterious Variant in Either of the BRCA Genes by Assessment of PFS.
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice