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NCT02354586 · OUTCOME

ORR by HRD Status and Breast Cancer Gene (BRCA) Status

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens · Source last updated 2022-09-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years

What was measured

The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).

Analysis population: ITT Population. All the participants from the ITT Population were analyzed (461 participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

Groups in this outcome

Niraparib 300 mg

Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg461

Reported measurements

HRD positive, n=221

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg221
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg14.0Not reported9.719.3Not reported
HRD negative, n=195

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg195
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg2.6Not reported0.85.9Not reported
HRD unknown, n=45

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg45
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg6.7Not reported1.418.3Not reported
BRCA mutation positive, n=87

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg87
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg23.0Not reported14.633.2Not reported
BRCA wild-type, n=317

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg317
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg5.0Not reported2.98.1Not reported
BRCA unknown, n=57

Analysis denominator · Participants

GroupSource count
Niraparib 300 mg57
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg5.3Not reported1.114.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.7
        upper Limit
        19.3
        value
        14.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      units
      Participants
    title
    HRD positive, n=221
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8
        upper Limit
        5.9
        value
        2.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        195
      units
      Participants
    title
    HRD negative, n=195
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        18.3
        value
        6.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    HRD unknown, n=45
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.6
        upper Limit
        33.2
        value
        23.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        87
      units
      Participants
    title
    BRCA mutation positive, n=87
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.9
        upper Limit
        8.1
        value
        5.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        317
      units
      Participants
    title
    BRCA wild-type, n=317
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        14.6
        value
        5.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    BRCA unknown, n=57
denoms
  1. counts
    1. group Id
      OG000
      value
      461
    units
    Participants
description
The ORR was defined as the percentage of participants achieving CR or PR as assessed by the Investigator per RECIST (version1.1), where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. ORR was evaluated for participants with following characteristics: HRD status (positive, negative and unknown) and BRCA status (mutation positive, wild-type and unknown).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
    id
    OG000
    title
    Niraparib 300 mg
param Type
NUMBER
population Description
ITT Population. All the participants from the ITT Population were analyzed (461 participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
reporting Status
POSTED
time Frame
Up to 3 years
title
ORR by HRD Status and Breast Cancer Gene (BRCA) Status
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice