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NCT02987543 · OUTCOME

Overall Survival (OS) - Cohort A Only

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) · Source last updated 2023-10-06

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
Approximately 35 months after the first patient was randomised.

What was measured

Number of Participants with Overall Survival (OS) - Cohort A only.

Analysis population: Full analysis set

Groups in this outcome

Cohort A Olaparib 300mg bd

2x150mg film-coated tablets

Cohort A Investigators Choice of NHA

either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort A Olaparib 300mg bd162
Cohort A Investigators Choice of NHA83

Reported measurements

Source class 1

Died

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A Olaparib 300mg bd91Not reportedNot reportedNot reportedNot reported
Cohort A Investigators Choice of NHA57Not reportedNot reportedNot reportedNot reported

Alive at data cut-off

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A Olaparib 300mg bd49Not reportedNot reportedNot reportedNot reported
Cohort A Investigators Choice of NHA21Not reportedNot reportedNot reportedNot reported

Terminated prior to death (withdrawn consent)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A Olaparib 300mg bd22Not reportedNot reportedNot reportedNot reported
Cohort A Investigators Choice of NHA5Not 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
    0.50
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0175
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.50
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.97
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0175
    p Value Comment
    2-sided p-value
    param Type
    Hazard Ratio (HR)
    param Value
    0.69
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        91
      2. group Id
        OG001
        value
        57
      title
      Died
    2. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        21
      title
      Alive at data cut-off
    3. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        5
      title
      Terminated prior to death (withdrawn consent)
denoms
  1. counts
    1. group Id
      OG000
      value
      162
    2. group Id
      OG001
      value
      83
    units
    Participants
description
Number of Participants with Overall Survival (OS) - Cohort A only.
groups
  1. description
    2x150mg film-coated tablets
    id
    OG000
    title
    Cohort A Olaparib 300mg bd
  2. description
    either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
    id
    OG001
    title
    Cohort A Investigators Choice of NHA
param Type
COUNT_OF_PARTICIPANTS
population Description
Full analysis set
reporting Status
POSTED
time Frame
Approximately 35 months after the first patient was randomised.
title
Overall Survival (OS) - Cohort A Only
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice