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NCT04569032 · OUTCOME

Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression · Source last updated 2026-08-13

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
From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)

What was measured

Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE

Analysis population: FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, "Overall Number of Participants Analyzed" were participants evaluable for this outcome measure however all participants reported under "Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows.

Groups in this outcome

CD30 <1% [Local Laboratory Assessment]

Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.

CD30 1% to <10% [Local Laboratory Assessment]

Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.

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

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]34
CD30 1% to <10% [Local Laboratory Assessment]48

Reported measurements

Hemoglobin decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]19Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]34Not reportedNot reportedNot reportedNot reported
Hemoglobin decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Leukocytes decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]13Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]23Not reportedNot reportedNot reportedNot reported
Leukocytes decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]5Not reportedNot reportedNot reportedNot reported
Leukocytes decreased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]10Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]15Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]15Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]21Not reportedNot reportedNot reportedNot reported
Lymphocytes decreased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]12Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
Neutrophils decreased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
Platelets decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]6Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]10Not reportedNot reportedNot reportedNot reported
Platelets decreased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Calcium Corrected for Albumin increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]32
CD30 1% to <10% [Local Laboratory Assessment]46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Creatinine increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]19Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]30Not reportedNot reportedNot reportedNot reported
Glomerular Filtration Rate, Estimated decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]18
CD30 1% to <10% [Local Laboratory Assessment]31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
Glucose decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]5Not reportedNot reportedNot reportedNot reported
Glucose increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]15Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]21Not reportedNot reportedNot reportedNot reported
Glucose increased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
Glucose increased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Phosphate decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]31
CD30 1% to <10% [Local Laboratory Assessment]46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Phosphate decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]31
CD30 1% to <10% [Local Laboratory Assessment]46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
Potassium decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]5Not reportedNot reportedNot reportedNot reported
Potassium decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Potassium decreased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]6Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]17Not reportedNot reportedNot reportedNot reported
Albumin decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]32
CD30 1% to <10% [Local Laboratory Assessment]46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]8Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]43
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]11Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase increased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]43
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]8Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]15Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase increased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Calcium Corrected for Albumin decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]32
CD30 1% to <10% [Local Laboratory Assessment]46
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
Potassium increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
Potassium increased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
Sodium decreased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]8Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]6Not reportedNot reportedNot reportedNot reported
Sodium decreased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]3Not reportedNot reportedNot reportedNot reported
Sodium increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
Total Bilirubin increased: Grade 1+2

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]1Not reportedNot reportedNot reportedNot reported
Urate increased: Grade 3

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]4Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]6Not reportedNot reportedNot reportedNot reported
Urate increased: Grade 4

Analysis denominator · Participants

GroupSource count
CD30 <1% [Local Laboratory Assessment]33
CD30 1% to <10% [Local Laboratory Assessment]47
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CD30 <1% [Local Laboratory Assessment]2Not reportedNot reportedNot reportedNot reported
CD30 1% to <10% [Local Laboratory Assessment]0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        34
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Hemoglobin decreased: Grade 1+2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Hemoglobin decreased: Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        23
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Leukocytes decreased: Grade 1+2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Leukocytes decreased: Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Leukocytes decreased: Grade 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        15
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Lymphocytes decreased: Grade 1+2
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        21
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Lymphocytes decreased: Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Lymphocytes decreased: Grade 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        12
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Neutrophils decreased: Grade 1+2
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Neutrophils decreased: Grade 3
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Neutrophils decreased: Grade 4
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        47
      units
      Participants
    title
    Platelets decreased: Grade 1+2
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      48
    units
    Participants
description
Any Abnormal laboratory tests(Decreased values of hemoglobin,leukocytes,lymphocytes,neutrophils, platelets, calcium corrected for albumin,glomerular filtration rate estimated, glucose, phosphate, potassium,albumin,sodium and increased values of calcium corrected for albumin,creatinine, potassium, glucose, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, total Bilirubin, urate) that worsen from baseline were considered clinically significant by investigator.Abnormal test were recorded as AE if associated with accompanying symptoms,required additional diagnostic testing or medical/surgical intervention,study dosing change,study discontinuation,significant additional concomitant drug treatment,other therapy.As perNCI CTCAE grade(G)1:mild(asymptomatic or mild symptoms,clinical,diagnostic observations,no intervention),G2:moderate(minimal, local,noninvasive intervention),G3:severe,medically significant,G4:life-threatening,urgent intervention,G5:death related to AE
groups
  1. description
    Participants with \<1% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 21-day cycle, Cyclophosphamide 750 milligram per square meter (mg/m\^2) IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
    id
    OG000
    title
    CD30 <1% [Local Laboratory Assessment]
  2. description
    Participants with 1% to \<10% CD30 expression (per local laboratory assessment) received A+CHP treatment in 21-day cycle. Brentuximab vedotin as 1.8 mg/kg IV on Day 1 of each 21-day cycle, Cyclophosphamide 750 mg/m\^2 IV on Day 1 of each 21-day cycle, Doxorubicin 50 mg/m\^2 IV on Day 1 of each 21-day cycle, Prednisone 100 mg orally on Days 1-5 of each 21-day cycle.
    id
    OG001
    title
    CD30 1% to <10% [Local Laboratory Assessment]
param Type
COUNT_OF_PARTICIPANTS
population Description
FAS included all participants who received any amount of brentuximab vedotin or any component of CHP. Here, "Overall Number of Participants Analyzed" were participants evaluable for this outcome measure however all participants reported under "Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, "Number Analyzed" signifies participants evaluable for the specified rows.
reporting Status
POSTED
time Frame
From first dose of the study treatment (Day 1) up to 30-37 days after the last dose of study treatment (approximately up to 6.6 months)
title
Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice