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NCT01193842 · OUTCOME

Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 5 years

What was measured

The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.

Analysis population: Eligible randomized participants

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-EPOCH45
Phase II: DA-R-EPOCH45

Reported measurements

Death
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH28.9Not reportedNot reportedNot reportedNot reported
Phase II: DA-R-EPOCH20.0Not reportedNot reportedNot reportedNot reported
Life-threatening
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH37.8Not reportedNot reportedNot reportedNot reported
Phase II: DA-R-EPOCH28.9Not reportedNot reportedNot reportedNot reported
Severe
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH20.0Not reportedNot reportedNot reportedNot reported
Phase II: DA-R-EPOCH31.1Not reportedNot reportedNot reportedNot reported
Moderate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH8.9Not reportedNot reportedNot reportedNot reported
Phase II: DA-R-EPOCH17.8Not reportedNot reportedNot reportedNot reported
Mild
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II: VR-DA-EPOCH2.2Not reportedNot reportedNot reportedNot reported
Phase II: DA-R-EPOCH0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28.9
      2. group Id
        OG001
        value
        20.0
    title
    Death
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        37.8
      2. group Id
        OG001
        value
        28.9
    title
    Life-threatening
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
      2. group Id
        OG001
        value
        31.1
    title
    Severe
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8.9
      2. group Id
        OG001
        value
        17.8
    title
    Moderate
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2.2
      2. group Id
        OG001
        value
        0
    title
    Mild
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      45
    units
    Participants
description
The percentage of participants with AEs and their worst severity will be tabulated for each treatment arm. If a participant has more than one AE, the most severe AE is analyzed. All adverse events will be assessed by the investigator from the first dose of protocol therapy through the post-treatment discontinuation visit. Participants are planned to be treated for a total of 6 cycles (21 day cycle length), or roughly 4 months. After this evaluation, assessment and reporting of AEs will only be required for all grade 5 AEs and any serious AE (SAE) that the investigator considers related to protocol therapy.
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
NUMBER
population Description
Eligible randomized participants
reporting Status
POSTED
time Frame
Up to 5 years
title
Percentage of Participant Experiencing Adverse Events (AEs) for Each Treatment Arm as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0) (Phase II)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice