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NCT01495598 · OUTCOME

Human Immunodeficiency Virus (HIV) Viral Load

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
Copies/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

HIV viral load in peripheral blood mononuclear cells was assessed by quantitative real-time polymerase chain reaction (PCR). The lower limit of detection for HIV viral load is \<50 copies mL.

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

Source class 1
Values in Copies/mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Baseline to 4 Weeks0Not reported00Not reported
Baseline to 8 Weeks0Not reported00Not reported
Baseline to End of Treatment0Not reported00Not 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
    0.56
    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
    0.65
    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
    0.56
    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
    0.56
    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
    0.65
    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
    0.56
    statistical Method
    Wilcoxon signed rank test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      28
    3. group Id
      OG002
      value
      28
    units
    Participants
description
HIV viral load in peripheral blood mononuclear cells was assessed by quantitative real-time polymerase chain reaction (PCR). The lower limit of detection for HIV viral load is \<50 copies mL.
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
Human Immunodeficiency Virus (HIV) Viral Load
type
SECONDARY
unit Of Measure
Copies/mL

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice