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NCT02041325 · OUTCOME

Phenotypic Changes

Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias · Source last updated 2016-05-17

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

Measure
MEDIAN
Unit
cells/cmm
Interval / dispersion
Full Range
Time frame
6 weeks

What was measured

Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.

Groups in this outcome

Lenalidomide

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Placebo

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide22
Placebo16

Reported measurements

Total T cells CD3+
Values in cells/cmm · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lenalidomide851.5Not reported6301570Not reported
Placebo715Not reported5311834Not reported
Helper T cells CD3+/CD4+
Values in cells/cmm · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lenalidomide591Not reported3881094Not reported
Placebo525Not reported3161055Not reported
Cytotoxic T cells CD3+/CD8+
Values in cells/cmm · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lenalidomide296Not reported77528Not reported
Placebo183Not reported1171243Not reported
Natural Killer cells CD56+/CD16+
Values in cells/cmm · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Lenalidomide249.5Not reported98662Not reported
Placebo228Not reported180418Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        630
        upper Limit
        1570
        value
        851.5
      2. group Id
        OG001
        lower Limit
        531
        upper Limit
        1834
        value
        715
    title
    Total T cells CD3+
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        388
        upper Limit
        1094
        value
        591
      2. group Id
        OG001
        lower Limit
        316
        upper Limit
        1055
        value
        525
    title
    Helper T cells CD3+/CD4+
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77
        upper Limit
        528
        value
        296
      2. group Id
        OG001
        lower Limit
        117
        upper Limit
        1243
        value
        183
    title
    Cytotoxic T cells CD3+/CD8+
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98
        upper Limit
        662
        value
        249.5
      2. group Id
        OG001
        lower Limit
        180
        upper Limit
        418
        value
        228
    title
    Natural Killer cells CD56+/CD16+
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      16
    units
    Participants
description
Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.
dispersion Type
Full Range
groups
  1. description
    Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
    id
    OG000
    title
    Lenalidomide
  2. description
    Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
    id
    OG001
    title
    Placebo
param Type
MEDIAN
reporting Status
POSTED
time Frame
6 weeks
title
Phenotypic Changes
type
SECONDARY
unit Of Measure
cells/cmm

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

Preserved source evidence · Not medical advice