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NCT01233921 · OUTCOME

Changes in the Number of Naive CD4 T Cells in the Blood

Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2014-04-02

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

Measure
MEAN
Unit
cells per microliter of blood
Interval / dispersion
Standard Deviation
Time frame
Baseline and 4 weeks after administration of palifermin

What was measured

Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.

Groups in this outcome

Arm I (Palifermin)

Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.

Arm II (no Palifermin)

Patients do not receive palifermin.

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

Analysis denominator · Participants

GroupSource count
Arm I (Palifermin)3
Arm II (no Palifermin)3

Reported measurements

Source class 1
Values in cells per microliter of blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Palifermin)-34Not reportedNot reportedNot reported
Arm II (no Palifermin)-2558Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4
        value
        -3
      2. group Id
        OG001
        spread
        58
        value
        -25
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Naive CD4 T cells will be defined according to co-expression of CD3, CD4, CD45RA, and CCR7. Positive results indicate an increase in the number of cells between baseline and 4 weeks. Negative results indicate a decrease in the number of cells between baseline and 4 weeks.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
    id
    OG000
    title
    Arm I (Palifermin)
  2. description
    Patients do not receive palifermin.
    id
    OG001
    title
    Arm II (no Palifermin)
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline and 4 weeks after administration of palifermin
title
Changes in the Number of Naive CD4 T Cells in the Blood
type
SECONDARY
unit Of Measure
cells per microliter of blood

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

Preserved source evidence · Not medical advice