NCT01282424 · OUTCOME

Idelalisib Plasma Concentration

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas · Source last updated 2019-07-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Predose and at 1.5 hours (± 5 minutes) postdose on Day 29

Analysis population: Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.

Groups in this outcome

Idelalisib

Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.

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
Idelalisib	125

Reported measurements

Predose

Analysis denominator · Participants

Group	Source count
Idelalisib	108

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Idelalisib	471.6	486.53	Not reported	Not reported	Not reported

Postdose

Analysis denominator · Participants

Group	Source count
Idelalisib	106

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Idelalisib	2187.7	1050.76	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
486.53
value
471.6
denoms
counts
group Id
OG000
value
108
units
Participants
title
Predose
categories
measurements
group Id
OG000
spread
1050.76
value
2187.7
denoms
counts
group Id
OG000
value
106
units
Participants
title
Postdose

denoms

counts
group Id
OG000
value
125
units
Participants

dispersion Type

Standard Deviation

groups

description
Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
id
OG000
title
Idelalisib

param Type

MEAN

population Description

Pharmacokinetic (PK) Analysis Set included participants in the ITT Analysis Set who had the necessary baseline and on-study measurements.

reporting Status

POSTED

time Frame

Predose and at 1.5 hours (± 5 minutes) postdose on Day 29

title

Idelalisib Plasma Concentration

type

SECONDARY

unit Of Measure

ng/mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice