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NCT02354586 · OUTCOME

Disease Control Rate (DCR)

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

Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval.

Analysis population: ITT Population. Only those participants with data available at the specified time points were analyzed.

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

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg49.02Not reported44.453.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        44.4
        upper Limit
        53.7
        value
        49.02
denoms
  1. counts
    1. group Id
      OG000
      value
      461
    units
    Participants
description
Disease control rate was defined as the percentage of participants achieving CR, PR, or stable disease (SD) as assessed by the Investigator per RECIST (version1.1). The exact (Clopper-Pearson) method was used to calculate 95% confidence interval.
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. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Up to 3 years
title
Disease Control Rate (DCR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice