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NCT01282424 · OUTCOME

PK Parameter: Tmax

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
Interval / dispersion
Inter-Quartile Range
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

Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).

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

Tmax at Day 1
Values in hours · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Idelalisib1.00Not reported0.991.04Not reported
Tmax at Day 29
Values in hours · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Idelalisib1.00Not reported0.952.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.99
        upper Limit
        1.04
        value
        1.00
    title
    Tmax at Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.95
        upper Limit
        2.00
        value
        1.00
    title
    Tmax at Day 29
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Tmax at Days 1 and 29 was analyzed. Tmax is defined as the time of Cmax (the maximum concentration of drug).
dispersion Type
Inter-Quartile Range
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: Tmax
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice