NCT01847274 · OUTCOME

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) 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*hour per milliliter
Interval / dispersion: Standard Deviation
Time frame: Pre-dose 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 AUC(0-infinity) of niraparib.

Analysis population: Pharmacokinetic population consisted of all participants who received at least one dose of study drug, with sufficient data available to calculate parameters. 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

Group	Source count
FE Niraparib Fasted	15
FE Niraparib Fed	14

Reported measurements

Source class 1

Values in Nanograms*hour per milliliter · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
FE Niraparib Fasted	29016.1	18405.23	Not reported	Not reported	Not reported
FE Niraparib Fed	31194	16894.88	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
0.997
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.216
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Ratio of Least square mean
param Value
1.10

Complete source fields

analyses

ci Lower Limit
0.997
ci Num Sides
TWO_SIDED
ci Pct Value
90
ci Upper Limit
1.216
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
param Type
Ratio of Least square mean
param Value
1.10

classes

categories
measurements
group Id
OG000
spread
18405.23
value
29016.1
group Id
OG001
spread
16894.88
value
31194

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
14
units
Participants

description

Blood samples were collected at indicated time points to analyze AUC(0-infinity) of niraparib.

dispersion Type

Standard Deviation

groups

description
Participants received Niraparib 300 mg in fasted condition
id
OG000
title
FE Niraparib Fasted
description
Participants received Niraparib 300 mg in fed condition
id
OG001
title
FE Niraparib Fed

param Type

MEAN

population Description

Pharmacokinetic population consisted of all participants who received at least one dose of study drug, with sufficient data available to calculate parameters. Only those participants with data available at the specified time points were analyzed.

reporting Status

POSTED

time Frame

Pre-dose and at 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post dose

title

Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0-infinity]) Following Administration of Niraparib (FE Sub-study)

type

SECONDARY

unit Of Measure

Nanograms*hour per milliliter

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

Preserved source evidence · Not medical advice