Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01777152 · OUTCOME

Incidence of Laboratory Abnormalities

ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas · Source last updated 2021-11-30

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 8.28 months

What was measured

Number of participants who experienced a Grade 3 or higher laboratory toxicity.

Analysis population: The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.

Groups in this outcome

A+CHP

brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

CHOP

cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles

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

Analysis denominator · Participants

GroupSource count
A+CHP223
CHOP226

Reported measurements

Any Chemistry Test
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP25Not reportedNot reportedNot reportedNot reported
CHOP23Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP3Not reportedNot reportedNot reportedNot reported
CHOP1Not reportedNot reportedNot reportedNot reported
Albumin Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP2Not reportedNot reportedNot reportedNot reported
CHOP3Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP1Not reportedNot reportedNot reportedNot reported
CHOP0Not reportedNot reportedNot reportedNot reported
Calcium Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP1Not reportedNot reportedNot reportedNot reported
CHOP1Not reportedNot reportedNot reportedNot reported
Glucose High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP8Not reportedNot reportedNot reportedNot reported
CHOP6Not reportedNot reportedNot reportedNot reported
Phosphate Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP4Not reportedNot reportedNot reportedNot reported
CHOP3Not reportedNot reportedNot reportedNot reported
Potassium High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP0Not reportedNot reportedNot reportedNot reported
CHOP2Not reportedNot reportedNot reportedNot reported
Potassium Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP3Not reportedNot reportedNot reportedNot reported
CHOP2Not reportedNot reportedNot reportedNot reported
Sodium High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP1Not reportedNot reportedNot reportedNot reported
CHOP0Not reportedNot reportedNot reportedNot reported
Sodium Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP4Not reportedNot reportedNot reportedNot reported
CHOP6Not reportedNot reportedNot reportedNot reported
Urate High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP5Not reportedNot reportedNot reportedNot reported
CHOP2Not reportedNot reportedNot reportedNot reported
Any Hematology Test
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP68Not reportedNot reportedNot reportedNot reported
CHOP78Not reportedNot reportedNot reportedNot reported
Absolute Neutrophil Count Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP17Not reportedNot reportedNot reportedNot reported
CHOP19Not reportedNot reportedNot reportedNot reported
Hemoglobin High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP1Not reportedNot reportedNot reportedNot reported
CHOP0Not reportedNot reportedNot reportedNot reported
Hemoglobin Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP9Not reportedNot reportedNot reportedNot reported
CHOP13Not reportedNot reportedNot reportedNot reported
Leukocytes Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP12Not reportedNot reportedNot reportedNot reported
CHOP21Not reportedNot reportedNot reportedNot reported
Lymphocytes High
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP0Not reportedNot reportedNot reportedNot reported
CHOP1Not reportedNot reportedNot reportedNot reported
Lymphocytes Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP52Not reportedNot reportedNot reportedNot reported
CHOP61Not reportedNot reportedNot reportedNot reported
Neutrophils Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP17Not reportedNot reportedNot reportedNot reported
CHOP19Not reportedNot reportedNot reportedNot reported
Platelets Low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
A+CHP1Not reportedNot reportedNot reportedNot reported
CHOP1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        23
    title
    Any Chemistry Test
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    title
    Alanine Aminotransferase High
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Albumin Low
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Alkaline Phosphatase High
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Calcium Low
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        6
    title
    Glucose High
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
    title
    Phosphate Low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Potassium High
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Potassium Low
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Sodium High
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
    title
    Sodium Low
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Urate High
denoms
  1. counts
    1. group Id
      OG000
      value
      223
    2. group Id
      OG001
      value
      226
    units
    Participants
description
Number of participants who experienced a Grade 3 or higher laboratory toxicity.
groups
  1. description
    brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    OG000
    title
    A+CHP
  2. description
    cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
    id
    OG001
    title
    CHOP
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
reporting Status
POSTED
time Frame
Up to 8.28 months
title
Incidence of Laboratory Abnormalities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice