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NCT01847274 · OUTCOME

Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation

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 date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days

What was measured

The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death

Analysis population: Intent-to-treat population

Groups in this outcome

Non-gBRCA Niraparib

Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.

Non-gBRCA Placebo

Participants without germline BRCA mutation received matching placebo once daily orally 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
Non-gBRCA Niraparib234
Non-gBRCA Placebo116

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-gBRCA Niraparib12.4Not reported10.914.5Not reported
Non-gBRCA Placebo7.4Not reported5.98.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.454
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.740
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Two-sided P-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.454
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.740
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Two-sided P-value.
    param Type
    Hazard Ratio (HR)
    param Value
    0.58
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.9
        upper Limit
        14.5
        value
        12.4
      2. group Id
        OG001
        lower Limit
        5.9
        upper Limit
        8.7
        value
        7.4
denoms
  1. counts
    1. group Id
      OG000
      value
      234
    2. group Id
      OG001
      value
      116
    units
    Participants
description
The TFST was defined as the time from the date of randomization to the start date of the first subsequent anti-cancer therapy or death
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
    id
    OG000
    title
    Non-gBRCA Niraparib
  2. description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
    id
    OG001
    title
    Non-gBRCA Placebo
param Type
MEDIAN
population Description
Intent-to-treat population
reporting Status
POSTED
time Frame
From date of randomization to the earliest date of first subsequent therapy or death, up to 7 years, 7 months and 4 days
title
Time to First Subsequent Therapy in Cohort With No Germline BRCA Mutation
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice