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NCT01193842 · OUTCOME

Changes in Human Herpes Virus (HHV)-8 Viral Load

Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21

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

Measure
MEDIAN
Unit
copies per 100uL
Interval / dispersion
Inter-Quartile Range
Time frame
Baseline up to 12 months

What was measured

Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.

Analysis population: Outcome measure is the difference between the baseline and specific time points (End of Cycle 2, Treatment discontinuation, 6-month, and 12-month follow-ups. Only a few differences can be calculated.

Groups in this outcome

Phase II: VR-DA-EPOCH

Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)

Phase II: DA-R-EPOCH

Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat

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

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH1
Phase II: DA-R-EPOCH2

Reported measurements

End of Cycle 2

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH0
Phase II: DA-R-EPOCH0
At treatment discontinuation

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH0
Phase II: DA-R-EPOCH1
Values in copies per 100uL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II: DA-R-EPOCH0Not reported00Not reported
6-month follow-up

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH0
Phase II: DA-R-EPOCH1
Values in copies per 100uL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II: DA-R-EPOCH0Not reported00Not reported
12-month follow-up

Analysis denominator · Participants

GroupSource count
Phase II: VR-DA-EPOCH1
Phase II: DA-R-EPOCH1
Values in copies per 100uL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH0Not reported00Not reported
Phase II: DA-R-EPOCH0Not reported00Not reported
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    End of Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    At treatment discontinuation
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    6-month follow-up
  4. 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
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    12-month follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    units
    Participants
description
Differences from baseline (specified follow-up assessment minus baseline) in (HHV)-8 viral load.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
    id
    OG000
    title
    Phase II: VR-DA-EPOCH
  2. description
    Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
    id
    OG001
    title
    Phase II: DA-R-EPOCH
param Type
MEDIAN
population Description
Outcome measure is the difference between the baseline and specific time points (End of Cycle 2, Treatment discontinuation, 6-month, and 12-month follow-ups. Only a few differences can be calculated.
reporting Status
POSTED
time Frame
Baseline up to 12 months
title
Changes in Human Herpes Virus (HHV)-8 Viral Load
type
SECONDARY
unit Of Measure
copies per 100uL

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

Preserved source evidence · Not medical advice