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NCT00628251 · OUTCOME

Overall Survival (OS)

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At the time of the cut-off for the final analysis of overall survival (30 April 2010)

What was measured

OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals

Groups in this outcome

Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

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 200 mg bd32
Olaparib 400 mg bd32
Liposomal Doxorubicin33

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd9Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd11Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin13Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5781
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3417
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.27
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9877
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.41
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.70
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 200 or 400 (n=64) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.5781
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
  2. ci Lower Limit
    0.27
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.55
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 200 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.3417
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.66
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
  3. ci Lower Limit
    0.44
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.27
    estimate Comment
    A hazard ratio of \<1 favoured olaparib.
    group Description
    Analysis of olaparib 400 (n=32) versus liposomal doxorubicin (n=33).
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.9877
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    1.01
    statistical Comment
    Analysis was performed using a Cox proportional hazards model with factors for treatment, BRCA status and platinum sensitivity.
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      33
    units
    Participants
description
OS was defined as time from randomisation to date of death from any cause. Patients who had not died at time of analysis were censored at last date they were known to be alive. Median OS was not calculable for olaparib groups due to an insufficient number of deaths so the percentage of participants who died are shown along with 95% confidence intervals
groups
  1. description
    Olaparib (AZD2281) 200 mg oral capsules twice daily
    id
    OG000
    title
    Olaparib 200 mg bd
  2. description
    Olaparib (AZD2281) 400 mg oral capsules twice daily
    id
    OG001
    title
    Olaparib 400 mg bd
  3. description
    Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
    id
    OG002
    title
    Liposomal Doxorubicin
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
At the time of the cut-off for the final analysis of overall survival (30 April 2010)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice