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NCT00396331 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) on Day 7

AMD3100 (Plerixafor) With G-CSF in Poor Mobilizing Adult Patients Who Previously Failed Hematopoietic Stem Cell (HSC) Collection/Attempts · Source last updated 2014-03-13

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
Day 7 (following fourth plerixafor administration)

What was measured

Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.

Analysis population: Participants who provided blood samples for pharmacokinetic (PK) analysis.

Groups in this outcome

PK Subpopulation

Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.

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 Subpopulation15

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
PK Subpopulation894227Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        227
        value
        894
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    units
    Participants
description
Maximum plasma concentration (Cmax) of plerixafor following daily doses of 240 µg/kg plerixafor, determined directly from the concentration-time data.
dispersion Type
Standard Deviation
groups
  1. description
    Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    PK Subpopulation
param Type
MEAN
population Description
Participants who provided blood samples for pharmacokinetic (PK) analysis.
reporting Status
POSTED
time Frame
Day 7 (following fourth plerixafor administration)
title
Maximum Observed Plasma Concentration (Cmax) on Day 7
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice