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NCT01495598 · OUTCOME

Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment

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
pg/mL
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment

What was measured

Cytokines were evaluated using MSD 96-Well Multiarray Proinflammatory 7-plex assay (MesoScale Discovery).

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.

Baseline to 8 Weeks

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

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.

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

Interferon gamma (ƴ)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks-0.3Not reported-4.71.4Not reported
Baseline to 8 Weeks-0.4Not reported-7.44.5Not reported
Baseline to End of Treatment-2.4Not reported-5.355.1Not reported
Interleukin 4 (IL4)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.07Not reported0.020.1Not reported
Baseline to 8 Weeks0.1Not reported0.040.2Not reported
Baseline to End of Treatment0.06Not reported0.0010.1Not reported
Interleukin 6 (IL6)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.4Not reported-0.041.8Not reported
Baseline to 8 Weeks0.3Not reported-0.31.1Not reported
Baseline to End of Treatment0.6Not reported-0.35.8Not reported
Interleukin 8 (IL8)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks71.9Not reported5.3163.1Not reported
Baseline to 8 Weeks64.8Not reported-0.2233.1Not reported
Baseline to End of Treatment47.5Not reported-9.1121.1Not reported
Interleukin 10 (IL10)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.1Not reported-0.11.4Not reported
Baseline to 8 Weeks-0.03Not reported-0.20.4Not reported
Baseline to End of Treatment-0.05Not reported-0.30.2Not reported
Interleukin 12 (IL12)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.02Not reported-0.080.09Not reported
Baseline to 8 Weeks0.00Not reported-0.070.09Not reported
Baseline to End of Treatment0.03Not reported-0.070.14Not reported
Interleukin 13 (IL13)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.7Not reported0.031.9Not reported
Baseline to 8 Weeks0.9Not reported0.01.7Not reported
Baseline to End of Treatment0.6Not reported-0.021.3Not reported
Tumor necrosis factor alpha (TNFα)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0.3Not reported-0.090.8Not reported
Baseline to 8 Weeks0.5Not reported0.10.8Not reported
Baseline to End of Treatment0.06Not reported-0.30.4Not reported
Interferon (IFN)-inducible protein 10 (IP-10)
Values in pg/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks76.5Not reported-214.5239.3Not reported
Baseline to 8 Weeks18.4Not reported-271.7216.6Not reported
Baseline to End of Treatment-73.3Not reported-335.7127.8Not 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
    \<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
    0.19
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    OTHER
    p Value
    0.72
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank 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
    0.005
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.06
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.007
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank test
  10. 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
    0.0003
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.0002
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.01
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    \<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
    0.19
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    OTHER
    p Value
    0.72
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.03
    p Value Comment
    The reported p-value is representative of the changes in levels of IFNƴ among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    <0.0001
    p Value Comment
    The reported p-value is representative of the changes in levels of IL4 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank 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
    0.005
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.06
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.007
    p Value Comment
    The reported p-value is representative of the changes in levels of IL6 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank test
  10. 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
    0.0003
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.0002
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    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
    0.01
    p Value Comment
    The reported p-value is representative of the changes in levels of IL8 among all participants. Two tailed Wilcoxon signed rank test without adjustment for multiple comparisons.
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.7
        upper Limit
        1.4
        value
        -0.3
      2. group Id
        OG001
        lower Limit
        -7.4
        upper Limit
        4.5
        value
        -0.4
      3. group Id
        OG002
        lower Limit
        -5.3
        upper Limit
        55.1
        value
        -2.4
    title
    Interferon gamma (ƴ)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.02
        upper Limit
        0.1
        value
        0.07
      2. group Id
        OG001
        lower Limit
        0.04
        upper Limit
        0.2
        value
        0.1
      3. group Id
        OG002
        lower Limit
        0.001
        upper Limit
        0.1
        value
        0.06
    title
    Interleukin 4 (IL4)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.04
        upper Limit
        1.8
        value
        0.4
      2. group Id
        OG001
        lower Limit
        -0.3
        upper Limit
        1.1
        value
        0.3
      3. group Id
        OG002
        lower Limit
        -0.3
        upper Limit
        5.8
        value
        0.6
    title
    Interleukin 6 (IL6)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        163.1
        value
        71.9
      2. group Id
        OG001
        lower Limit
        -0.2
        upper Limit
        233.1
        value
        64.8
      3. group Id
        OG002
        lower Limit
        -9.1
        upper Limit
        121.1
        value
        47.5
    title
    Interleukin 8 (IL8)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.1
        upper Limit
        1.4
        value
        0.1
      2. group Id
        OG001
        lower Limit
        -0.2
        upper Limit
        0.4
        value
        -0.03
      3. group Id
        OG002
        lower Limit
        -0.3
        upper Limit
        0.2
        value
        -0.05
    title
    Interleukin 10 (IL10)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.08
        upper Limit
        0.09
        value
        0.02
      2. group Id
        OG001
        lower Limit
        -0.07
        upper Limit
        0.09
        value
        0.00
      3. group Id
        OG002
        lower Limit
        -0.07
        upper Limit
        0.14
        value
        0.03
    title
    Interleukin 12 (IL12)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.03
        upper Limit
        1.9
        value
        0.7
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        1.7
        value
        0.9
      3. group Id
        OG002
        lower Limit
        -0.02
        upper Limit
        1.3
        value
        0.6
    title
    Interleukin 13 (IL13)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.09
        upper Limit
        0.8
        value
        0.3
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        0.8
        value
        0.5
      3. group Id
        OG002
        lower Limit
        -0.3
        upper Limit
        0.4
        value
        0.06
    title
    Tumor necrosis factor alpha (TNFα)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -214.5
        upper Limit
        239.3
        value
        76.5
      2. group Id
        OG001
        lower Limit
        -271.7
        upper Limit
        216.6
        value
        18.4
      3. group Id
        OG002
        lower Limit
        -335.7
        upper Limit
        127.8
        value
        -73.3
    title
    Interferon (IFN)-inducible protein 10 (IP-10)
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      28
    3. group Id
      OG002
      value
      28
    units
    Participants
description
Cytokines were evaluated using MSD 96-Well Multiarray Proinflammatory 7-plex assay (MesoScale Discovery).
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.
    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.
    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.
    id
    OG002
    title
    Baseline to End of Treatment
param Type
MEDIAN
reporting Status
POSTED
time Frame
Baseline to 4 weeks, baseline to 8 weeks and baseline to end of treatment
title
Change in Cytokines From Baseline to 4 Weeks, Baseline to 8 Weeks and End of Treatment
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice