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NCT05673785 · OUTCOME

Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements

A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) · Source last updated 2026-06-12

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 7 months

What was measured

Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed. Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Analysis population: The FAS consisted of all enrolled participants.

Groups in this outcome

Brentuximab Vedotin + CHP

Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Brentuximab Vedotin + CHP52

Reported measurements

Postbaseline Shift From Grade 0 to Grade 4 Low Potassium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From Grade 0 to Grade 3 AST
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From Grade 0 to Grade 3 Bilirubin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From Grade 0 to Grade 3 Serum GGT
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP2Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From Grade 0 to Grade 3 High Glucose (Hyperglycemia),
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP2Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From Grade 0 to Grade 3 Low Potassuium
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP2Not reportedNot reportedNot reportedNot reported
Postbaseline Serum Total Bilirubin >=2 ULN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP0Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Neutrophil Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP8Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Leukocyte Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP6Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Platelet Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Leukocyte Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP6Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Neutrophil Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP3Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Platelet Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP2Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 1 to Grade 3 Low Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP3Not reportedNot reportedNot reportedNot reported
Postbaseline Shift From CTCAE Grade 1 to Grade 3 Low Leucocyte Count
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin + CHP1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Postbaseline Shift From Grade 0 to Grade 4 Low Potassium
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Postbaseline Shift From Grade 0 to Grade 3 AST
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Postbaseline Shift From Grade 0 to Grade 3 Bilirubin
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Postbaseline Shift From Grade 0 to Grade 3 Serum GGT
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Postbaseline Shift From Grade 0 to Grade 3 High Glucose (Hyperglycemia),
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Postbaseline Shift From Grade 0 to Grade 3 Low Potassuium
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Postbaseline Serum Total Bilirubin >=2 ULN
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Neutrophil Count
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Leukocyte Count
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Platelet Count
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Leukocyte Count
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Neutrophil Count
denoms
  1. counts
    1. group Id
      OG000
      value
      52
    units
    Participants
description
Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed. Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
groups
  1. description
    Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
    id
    OG000
    title
    Brentuximab Vedotin + CHP
param Type
COUNT_OF_PARTICIPANTS
population Description
The FAS consisted of all enrolled participants.
reporting Status
POSTED
time Frame
Up to approximately 7 months
title
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice