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NCT00866047 · OUTCOME

Chemistry Laboratory Abnormalities >/= Grade 3

A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma · Source last updated 2017-03-22

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
up to 12 months

What was measured

Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

Analysis population: All participants who received treatment

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion

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 Vedotin58

Reported measurements

Any >/= Grade 3 chemistry laboratory abnormality
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin13Not reportedNot reportedNot reportedNot reported
Aspartate aminotransferase (high)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1Not reportedNot reportedNot reportedNot reported
Calcium (low)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3Not reportedNot reportedNot reportedNot reported
Glucose (high)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin4Not reportedNot reportedNot reportedNot reported
Potassium (low)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1Not reportedNot reportedNot reportedNot reported
Sodium (low)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin1Not reportedNot reportedNot reportedNot reported
Urate (high)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Any >/= Grade 3 chemistry laboratory abnormality
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Aspartate aminotransferase (high)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Calcium (low)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Glucose (high)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Potassium (low)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Sodium (low)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Urate (high)
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
    id
    OG000
    title
    Brentuximab Vedotin
param Type
NUMBER
population Description
All participants who received treatment
reporting Status
POSTED
time Frame
up to 12 months
title
Chemistry Laboratory Abnormalities >/= Grade 3
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice