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NCT01847274 · OUTCOME

Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)

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
Hour
Interval / dispersion
Full Range
Time frame
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

What was measured

Blood samples were collected at indicated time points to analyze the tmax of niraparib.

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

Groups in this outcome

FE Niraparib Fasted

Participants received Niraparib 300 mg in fasted condition

FE Niraparib Fed

Participants received Niraparib 300 mg in fed condition

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

Analysis denominator · Participants

GroupSource count
FE Niraparib Fasted16
FE Niraparib Fed15

Reported measurements

Source class 1
Values in Hour · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
FE Niraparib Fasted3.1Not reported1.76.1Not reported
FE Niraparib Fed6.1Not reported1.223Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        6.1
        value
        3.1
      2. group Id
        OG001
        lower Limit
        1.2
        upper Limit
        23
        value
        6.1
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Blood samples were collected at indicated time points to analyze the tmax of niraparib.
dispersion Type
Full Range
groups
  1. description
    Participants received Niraparib 300 mg in fasted condition
    id
    OG000
    title
    FE Niraparib Fasted
  2. description
    Participants received Niraparib 300 mg in fed condition
    id
    OG001
    title
    FE Niraparib Fed
param Type
MEDIAN
population Description
Pharmacokinetic population. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Pre-dose (Day -1) and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose
title
Time to Reach Maximum (Tmax) Following Administration of Niraparib (FE Sub-study)
type
SECONDARY
unit Of Measure
Hour

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

Preserved source evidence · Not medical advice