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NCT03732820 · OUTCOME

Number of Participants With First Symptomatic Skeletal Related Event (SSRE)

Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer · Source last updated 2026-08-18

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
Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

What was measured

An SSRE event is defined as the first sympomatic skeletal-related event defined by * Use of radiation therapy to prevent or relieve skeletal symptoms. * Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).

Analysis population: Full Analysis Set (FAS)

Groups in this outcome

Olaparib 300 mg bd + Abiraterone 1000 mg qd

Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily

Placebo bd + Abiraterone 1000 mg qd

Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once 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 300 mg bd + Abiraterone 1000 mg qd399
Placebo bd + Abiraterone 1000 mg qd397

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd + Abiraterone 1000 mg qd46Not reportedNot reportedNot reportedNot reported
Placebo bd + Abiraterone 1000 mg qd51Not 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
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.22
    estimate Comment
    HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3212
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Comment
    Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.22
    estimate Comment
    HR and CI calculated using Cox Proportional Hazards model, where a HR \< 1 favours olaparib+abiraterone. Stratification factors are the same as those used in the stratified log-rank test.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3212
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
    statistical Comment
    Log rank test stratified by Metastases and Docetaxel at metastatic hormone-sensitive prostate cancer stage using a pre-specified pooling strategy.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      399
    2. group Id
      OG001
      value
      397
    units
    Participants
description
An SSRE event is defined as the first sympomatic skeletal-related event defined by * Use of radiation therapy to prevent or relieve skeletal symptoms. * Occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral).
groups
  1. description
    Patients receive oral treatment with olaparib 300mg twice daily in combination with abiraterone 1000mg once daily
    id
    OG000
    title
    Olaparib 300 mg bd + Abiraterone 1000 mg qd
  2. description
    Patients receive oral treatment with placebo twice daily in combination with abiraterone 1000mg once daily.
    id
    OG001
    title
    Placebo bd + Abiraterone 1000 mg qd
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS)
reporting Status
POSTED
time Frame
Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
title
Number of Participants With First Symptomatic Skeletal Related Event (SSRE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice