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NCT00396266 · OUTCOME

Single-dose Time to Maximum Concentration of Plerixafor (Tmax)

AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF · Source last updated 2014-03-07

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Day 5 - 0 to 10 hours post-first plerixafor dose

What was measured

Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.

Analysis population: Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).

Groups in this outcome

PK Subgroup

Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.

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

Analysis denominator · Participants

GroupSource count
PK Subgroup13

Reported measurements

Source class 1
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
PK Subgroup0.50.20.31.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        spread
        0.2
        upper Limit
        1.0
        value
        0.5
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Evaluation of Tmax following a single dose of 240 µg/kg plerixafor administered after 4 days of G-CSF mobilization. Tmax was determined from direct observation of the data.
dispersion Type
Full Range
groups
  1. description
    Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
    id
    OG000
    title
    PK Subgroup
param Type
MEDIAN
population Description
Pharmacokinetic analysis was performed on a subgroup of participants from both treatment arms (5 NHL and 8 MM).
reporting Status
POSTED
time Frame
Day 5 - 0 to 10 hours post-first plerixafor dose
title
Single-dose Time to Maximum Concentration of Plerixafor (Tmax)
type
SECONDARY
unit Of Measure
hours

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

Preserved source evidence · Not medical advice