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NCT01847274 · OUTCOME

Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer · Source last updated 2023-06-02

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
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days

What was measured

Overall survival was defined as the date of randomization to the date of death by any cause.

Analysis population: Intent-to-treat population

Groups in this outcome

gBRCA Niraparib

Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.

gBRCA Placebo

Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.

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

Analysis denominator · Participants

GroupSource count
gBRCA Niraparib138
gBRCA Placebo65

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
gBRCA Niraparib40.9Not reported34.952.9Not reported
gBRCA Placebo38.1Not reported27.647.3Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.606
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.198
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3580
    p Value Comment
    Two-sided P-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.606
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.198
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3580
    p Value Comment
    Two-sided P-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.9
        upper Limit
        52.9
        value
        40.9
      2. group Id
        OG001
        lower Limit
        27.6
        upper Limit
        47.3
        value
        38.1
denoms
  1. counts
    1. group Id
      OG000
      value
      138
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Overall survival was defined as the date of randomization to the date of death by any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
    id
    OG000
    title
    gBRCA Niraparib
  2. description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
    id
    OG001
    title
    gBRCA Placebo
param Type
MEDIAN
population Description
Intent-to-treat population
reporting Status
POSTED
time Frame
From treatment randomization to date of death by any cause, up to 7 years, 7 months and 4 days
title
Overall Survival in Cohort With Germline BRCA Mutation (gBRCA)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice