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NCT01282424 · OUTCOME

PK Parameter: AUClast

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
hours x ng/mL
Interval / dispersion
Standard Deviation
Time frame
Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29

What was measured

AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration

Analysis population: Participants in the PK Analysis Set with available data were analyzed.

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

GroupSource count
Idelalisib8

Reported measurements

AUClast at Day 1
Values in hours x ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Idelalisib9094.762960.391Not reportedNot reportedNot reported
AUClast at Day 29
Values in hours x ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Idelalisib9293.393996.826Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2960.391
        value
        9094.76
    title
    AUClast at Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3996.826
        value
        9293.39
    title
    AUClast at Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
AUClast at Days 1 and 29 was analyzed. AUClast is defined as the concentration of drug from time zero to the last observable concentration
dispersion Type
Standard Deviation
groups
  1. 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
Participants in the PK Analysis Set with available data were analyzed.
reporting Status
POSTED
time Frame
Predose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Days 1 and 29
title
PK Parameter: AUClast
type
SECONDARY
unit Of Measure
hours x ng/mL

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

Preserved source evidence · Not medical advice