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NCT01874353 · OUTCOME

Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)

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
Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.

What was measured

To determine the efficacy 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 by assessment of time from randomization to first subsequent therapy or death (TFST).

Analysis population: Full Analysis Set (FAS) consisting of all patients randomized as part of global enrolment (excluding China). 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)27.4Not reported22.631.1Not reported
Placebo Tablets (Global Cohort)7.2Not reported6.38.5Not reported
Olaparib 300mg Tablets (China Cohort)13.9Not reported9.115.9Not reported
Placebo Tablets (China Cohort)5.5Not reported1.418.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.48
    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
    0.37
    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
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    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
    0.47
    statistical Comment
    Model includes a treatment factor only
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.28
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.48
    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
    0.37
    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
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    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
    0.47
    statistical Comment
    Model includes a treatment factor only
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.6
        upper Limit
        31.1
        value
        27.4
      2. group Id
        OG001
        lower Limit
        6.3
        upper Limit
        8.5
        value
        7.2
      3. group Id
        OG002
        lower Limit
        9.1
        upper Limit
        15.9
        value
        13.9
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        18.4
        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 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 by assessment of time from randomization to first subsequent therapy or death (TFST).
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). China Full Analysis Set (FAS) includes all patients who were randomised at sites in China.
reporting Status
POSTED
time Frame
Time elapsed from randomization to first subsequent therapy or death. Assessed every 12 weeks following treatment discontinuation. Assessed until 03 Feb 2020 DCO; up to a maximum of 75 months.
title
Efficacy of Olaparib by Time to First Subsequent Therapy or Death (TFST)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice