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NCT02354586 · OUTCOME

Time to First Subsequent Therapy (TFST)

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

Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of \[First dose of first subsequent therapy or death\] minus First dose date plus 1) divided by 30.4375.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Niraparib 300 mg6.8Not reported5.97.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.9
        upper Limit
        7.5
        value
        6.8
denoms
  1. counts
    1. group Id
      OG000
      value
      461
    units
    Participants
description
Time to first subsequent therapy (TFST) was defined as the time from the date of first dose to the date of first subsequent therapy or death, whichever occurs first. It was calculated as (Earlier of \[First dose of first subsequent therapy or death\] minus First dose date plus 1) divided by 30.4375.
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
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
Time to First Subsequent Therapy (TFST)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice