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NCT01847274 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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
MEAN
Unit
Nanograms per milliliter
Interval / dispersion
Standard Deviation
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 maximum observed plasma concentration 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 Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
FE Niraparib Fasted803.7403.35Not reportedNot reportedNot reported
FE Niraparib Fed582.1228.57Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.695
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.886
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of Least square mean
    param Value
    0.785
Complete source fields
analyses
  1. ci Lower Limit
    0.695
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.886
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Ratio of Least square mean
    param Value
    0.785
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        403.35
        value
        803.7
      2. group Id
        OG001
        spread
        228.57
        value
        582.1
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 maximum observed plasma concentration of niraparib.
dispersion Type
Standard Deviation
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
MEAN
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
Maximum Observed Plasma Concentration (Cmax) Following Administration of Niraparib (FE Sub-study)
type
SECONDARY
unit Of Measure
Nanograms per milliliter

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

Preserved source evidence · Not medical advice