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NCT03732820 · OUTCOME

Brief Pain Inventory-Short Form (BPI-SF)

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
LEAST_SQUARES_MEAN
Unit
Score
Interval / dispersion
Standard Error
Time frame
Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)

What was measured

The BPI-SF is a validated, 15-item domain-specific instrument designed to assess the severity of pain and the impact/interference of pain on daily functions. BPI-SF worst pain, pain severity and pain interference score changes can be a minimum of -10 and a maximum of 10. A negative change from baseline value indicates improvement.

Analysis population: Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.

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 qd330
Placebo bd + Abiraterone 1000 mg qd333

Reported measurements

Change from baseline in BPI-SF worst pain
Values in Score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd + Abiraterone 1000 mg qd-0.090.093Not reportedNot reportedNot reported
Placebo bd + Abiraterone 1000 mg qd0.030.099Not reportedNot reportedNot reported
Change from baseline in BPI-SF pain severity score
Values in Score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd + Abiraterone 1000 mg qd-0.080.071Not reportedNot reportedNot reported
Placebo bd + Abiraterone 1000 mg qd-0.020.076Not reportedNot reportedNot reported
Change from baseline in BPI-SF pain interference score
Values in Score · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Olaparib 300 mg bd + Abiraterone 1000 mg qd0.010.074Not reportedNot reportedNot reported
Placebo bd + Abiraterone 1000 mg qd0.130.079Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.093
        value
        -0.09
      2. group Id
        OG001
        spread
        0.099
        value
        0.03
    title
    Change from baseline in BPI-SF worst pain
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.071
        value
        -0.08
      2. group Id
        OG001
        spread
        0.076
        value
        -0.02
    title
    Change from baseline in BPI-SF pain severity score
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.074
        value
        0.01
      2. group Id
        OG001
        spread
        0.079
        value
        0.13
    title
    Change from baseline in BPI-SF pain interference score
denoms
  1. counts
    1. group Id
      OG000
      value
      330
    2. group Id
      OG001
      value
      333
    units
    Participants
description
The BPI-SF is a validated, 15-item domain-specific instrument designed to assess the severity of pain and the impact/interference of pain on daily functions. BPI-SF worst pain, pain severity and pain interference score changes can be a minimum of -10 and a maximum of 10. A negative change from baseline value indicates improvement.
dispersion Type
Standard Error
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
LEAST_SQUARES_MEAN
population Description
Full Analysis Set (FAS), only patients with baseline assessment and at least one post treatment assessment are included in the analysis.
reporting Status
POSTED
time Frame
Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
title
Brief Pain Inventory-Short Form (BPI-SF)
type
SECONDARY
unit Of Measure
Score

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

Preserved source evidence · Not medical advice