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NCT01492088 · OUTCOME

Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma · Source last updated 2024-05-30

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
From the first dose through 30 days after the last dose of study medication (Up to 15 months)

What was measured

Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.

Analysis population: Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.

Groups in this outcome

Brentuximab Vedotin 1.4 mg/kg: Phase 1

Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.

Brentuximab Vedotin 1.8 mg/kg: Phase 1

Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.

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 1.4 mg/kg: Phase 13
Brentuximab Vedotin 1.8 mg/kg: Phase 19

Reported measurements

Gamma-glutamyltransferase increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Transaminases increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Blood bicarbonate decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Weight decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Hypocalaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 12Not reportedNot reportedNot reportedNot reported
Hyperuricaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin 1.4 mg/kg: Phase 10Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin 1.8 mg/kg: Phase 11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Gamma-glutamyltransferase increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Transaminases increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Lymphocyte count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Neutrophil count decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Blood bicarbonate decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Weight decreased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Hypocalaemia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Hyperuricaemia
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
groups
  1. description
    Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Brentuximab Vedotin 1.4 mg/kg: Phase 1
  2. description
    Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
    id
    OG001
    title
    Brentuximab Vedotin 1.8 mg/kg: Phase 1
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
reporting Status
POSTED
time Frame
From the first dose through 30 days after the last dose of study medication (Up to 15 months)
title
Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice