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NCT01495598 · OUTCOME

Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV)

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
MEDIAN
Unit
cells/µL
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline to 4 weeks, baseline to 8 weeks, and baseline to end of treatment

What was measured

Fluorescence activated cell sorting.

Analysis population: HIV+ participants = 18.

Groups in this outcome

Baseline to 4 Weeks

Baseline to 4 weeks for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.

Baseline to 8 Weeks

Baseline to 8 weeks for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.

Baseline to End of Treatment

Baseline to end of treatment for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.

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

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks28
Baseline to 8 Weeks28
Baseline to End of Treatment28

Reported measurements

CD4+/All participants

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks28
Baseline to 8 Weeks28
Baseline to End of Treatment28
Values in cells/µL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks66.5Not reported-77.5221Not reported
Baseline to 8 Weeks37Not reported-57.0176.0Not reported
Baseline to End of Treatment-54Not reported-178.591.5Not reported
CD4+ among HIV+ participants

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks18
Baseline to 8 Weeks18
Baseline to End of Treatment18
Values in cells/µL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks72Not reported-29257Not reported
Baseline to 8 Weeks37Not reported-15291Not reported
Baseline to End of Treatment-14Not reported-79132Not reported
CD8+/All participants

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks28
Baseline to 8 Weeks28
Baseline to End of Treatment28
Values in cells/µL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks104.5Not reported-76.5257Not reported
Baseline to 8 Weeks115Not reported-19288Not reported
Baseline to End of Treatment73Not reported-38.5194.5Not reported
CD8+ among HIV+ participants

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks18
Baseline to 8 Weeks18
Baseline to End of Treatment18
Values in cells/µL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks198Not reported-20414Not reported
Baseline to 8 Weeks129Not reported1430Not reported
Baseline to End of Treatment75Not reported-102295Not reported
CD19+/All participants

Analysis denominator · Participants

GroupSource count
Baseline to 4 Weeks28
Baseline to 8 Weeks28
Baseline to End of Treatment28
Values in cells/µL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks-40Not reported-73-3.5Not reported
Baseline to 8 Weeks-55Not reported-1235Not reported
Baseline to End of Treatment-75Not reported-124.5-49.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.07
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  2. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.13
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  3. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.15
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  4. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  5. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.06
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  6. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.79
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon rank sum test
  7. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  8. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.008
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  9. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.12
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  10. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  11. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  12. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.36
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.07
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  2. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    0.13
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  3. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.15
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  4. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  5. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.06
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  6. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.79
    p Value Comment
    The reported p-value is representative of the changes in levels of CD4+cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon rank sum test
  7. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  8. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.008
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  9. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.12
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among all participants.
    statistical Method
    Wilcoxon signed rank test
  10. group Ids
    1. OG000
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  11. group Ids
    1. OG001
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.02
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
  12. group Ids
    1. OG002
    non Inferiority Comment
    P\<0.005 was considered statistically significant while 0.005 \<P\<0.05 was considered evidence of a strong trend.
    non Inferiority Type
    OTHER
    p Value
    0.36
    p Value Comment
    The reported p-value is representative of the changes in levels of CD8+ cells/µL among HIV+ participants.
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -77.5
        upper Limit
        221
        value
        66.5
      2. group Id
        OG001
        lower Limit
        -57.0
        upper Limit
        176.0
        value
        37
      3. group Id
        OG002
        lower Limit
        -178.5
        upper Limit
        91.5
        value
        -54
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        28
      units
      Participants
    title
    CD4+/All participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -29
        upper Limit
        257
        value
        72
      2. group Id
        OG001
        lower Limit
        -15
        upper Limit
        291
        value
        37
      3. group Id
        OG002
        lower Limit
        -79
        upper Limit
        132
        value
        -14
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        18
      units
      Participants
    title
    CD4+ among HIV+ participants
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -76.5
        upper Limit
        257
        value
        104.5
      2. group Id
        OG001
        lower Limit
        -19
        upper Limit
        288
        value
        115
      3. group Id
        OG002
        lower Limit
        -38.5
        upper Limit
        194.5
        value
        73
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        28
      units
      Participants
    title
    CD8+/All participants
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -20
        upper Limit
        414
        value
        198
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        430
        value
        129
      3. group Id
        OG002
        lower Limit
        -102
        upper Limit
        295
        value
        75
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        18
      3. group Id
        OG002
        value
        18
      units
      Participants
    title
    CD8+ among HIV+ participants
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -73
        upper Limit
        -3.5
        value
        -40
      2. group Id
        OG001
        lower Limit
        -123
        upper Limit
        5
        value
        -55
      3. group Id
        OG002
        lower Limit
        -124.5
        upper Limit
        -49.5
        value
        -75
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        28
      3. group Id
        OG002
        value
        28
      units
      Participants
    title
    CD19+/All participants
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      28
    3. group Id
      OG002
      value
      28
    units
    Participants
description
Fluorescence activated cell sorting.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Baseline to 4 weeks for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.
    id
    OG000
    title
    Baseline to 4 Weeks
  2. description
    Baseline to 8 weeks for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.
    id
    OG001
    title
    Baseline to 8 Weeks
  3. description
    Baseline to end of treatment for participants treated with pomalidomide 5 mg by mouth (p.o.) for 21 of 28 days. Includes 18 HIV+ participants.
    id
    OG002
    title
    Baseline to End of Treatment
param Type
MEDIAN
population Description
HIV+ participants = 18.
reporting Status
POSTED
time Frame
Baseline to 4 weeks, baseline to 8 weeks, and baseline to end of treatment
title
Change in Immune Cytokines Cluster of Differentiation 4 (CD4), Cluster of Differentiation 8 (CD8) and Cluster of Differentiation 19 (CD19) Among Participants With and/or Without Human Immunodeficiency Virus (HIV)
type
SECONDARY
unit Of Measure
cells/µL

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Preserved source evidence · Not medical advice