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NCT02184195 · OUTCOME

Overall Survival (OS)

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy · Source last updated 2023-09-13

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
Upto 4 years

What was measured

To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.

Analysis population: Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.

Groups in this outcome

Olaparib 300 mg Twice Daily (bd)

Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

Placebo

Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

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 Twice Daily (bd)92
Placebo62

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)19.0Not reported15.2826.32Not reported
Placebo19.2Not reported14.3226.12Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.564
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.224
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.3487
    param Type
    Hazard Ratio (HR)
    param Value
    0.831
    statistical Method
    Log-rank test
Complete source fields
analyses
  1. ci Lower Limit
    0.564
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.224
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.3487
    param Type
    Hazard Ratio (HR)
    param Value
    0.831
    statistical Method
    Log-rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.28
        upper Limit
        26.32
        value
        19.0
      2. group Id
        OG001
        lower Limit
        14.32
        upper Limit
        26.12
        value
        19.2
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      62
    units
    Participants
description
To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    OG000
    title
    Olaparib 300 mg Twice Daily (bd)
  2. description
    Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.
reporting Status
POSTED
time Frame
Upto 4 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice