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NCT01775475 · OUTCOME

Change in Absolute CD4 Count From Baseline to Post-treatment

Intravenous Chemotherapy or Oral Chemotherapy in Treating Patients With Previously Untreated Stage III-IV HIV-Associated Non-Hodgkin Lymphoma · Source last updated 2022-10-10

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

Measure
MEAN
Unit
cells per mm^3
Interval / dispersion
Standard Deviation
Time frame
From baseline to 18 weeks

What was measured

Change in absolute CD4 count from baseline to post-treatment (visit 6)

Analysis population: Participants who had absolute CD4 count measurements at baseline and visit 6

Groups in this outcome

Arm I (CHOP)

Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies

Arm II (Oral Chemotherapy)

Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Arm I (CHOP)3
Arm II (Oral Chemotherapy)3

Reported measurements

Source class 1
Values in cells per mm^3 · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (CHOP)-41.3136.5Not reportedNot reportedNot reported
Arm II (Oral Chemotherapy)203.3153.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        136.5
        value
        -41.3
      2. group Id
        OG001
        spread
        153.1
        value
        203.3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Change in absolute CD4 count from baseline to post-treatment (visit 6)
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive CHOP chemotherapy comprising cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Arm I (CHOP)
  2. description
    Patients receive lomustine PO QD on day 1 (courses 1 and 3 only), etoposide PO QD on days 1-3, cyclophosphamide PO QD on days 22-26, and procarbazine hydrochloride PO QD on days 22-26. Treatment repeats every 6 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. lomustine: Given PO etoposide: Given PO cyclophosphamide: Given PO procarbazine hydrochloride: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG001
    title
    Arm II (Oral Chemotherapy)
param Type
MEAN
population Description
Participants who had absolute CD4 count measurements at baseline and visit 6
reporting Status
POSTED
time Frame
From baseline to 18 weeks
title
Change in Absolute CD4 Count From Baseline to Post-treatment
type
PRIMARY
unit Of Measure
cells per mm^3

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

Preserved source evidence · Not medical advice