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NCT01495598 · OUTCOME

Maximal Plasma Concentration (Cmax) of Pomalidomide

Pomalidomide for Kaposi Sarcoma in People With or Without HIV · Source last updated 2022-11-01

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
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.

What was measured

Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).

Groups in this outcome

All Participants - Pomalidomide 5mg Daily

All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants - Pomalidomide 5mg Daily28

Reported measurements

Cycle 1 Day 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily53.127.0Not reportedNot reportedNot reported
Cycle 1 Day 15
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants - Pomalidomide 5mg Daily59.029.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.0
        value
        53.1
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.6
        value
        59.0
    title
    Cycle 1 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    units
    Participants
description
Plasma concentrations of pomalidomide were assayed using high-performance liquid chromatography with fluorescence detection with a lower limit of quantitation of 1 ng/mL and were recorded as observed values. A non-compartmental analysis was used to calculate plasma pharmacokinetic parameters (Pharsight, Mountain View, California).
dispersion Type
Standard Deviation
groups
  1. description
    All participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days.
    id
    OG000
    title
    All Participants - Pomalidomide 5mg Daily
param Type
MEAN
reporting Status
POSTED
time Frame
At pre-dose, 1, 2, 3, 4, 6, and 8 hours after dose on Cycle 1 Day 1, and pre-dose, 1, 2, 3, 4, 6, 8, and 24 hours after dose on Cycle 1 Day 15.
title
Maximal Plasma Concentration (Cmax) of Pomalidomide
type
PRIMARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice