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NCT02354586 · OUTCOME

Duration of Response (DoR)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years

What was measured

DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method.

Analysis population: Intent-to-Treat (ITT) Population was comprised of all dosed participants with measurable disease at Baseline. Measurable disease at Baseline was determined by the existence of at least 1 target lesion at Baseline tumor scan based on investigator's assessment. 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 mg39

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg9.4Not reported6.618.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.6
        upper Limit
        18.3
        value
        9.4
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
DoR was defined as the time from first documentation of CR or PR until the time of first documentation of disease progression (PD) as assessed by the Investigator per RECIST (version1.1). DoR was analyzed using Kaplan-Meier (KM) method.
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
MEDIAN
population Description
Intent-to-Treat (ITT) Population was comprised of all dosed participants with measurable disease at Baseline. Measurable disease at Baseline was determined by the existence of at least 1 target lesion at Baseline tumor scan based on investigator's assessment. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Up to 3 years
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice