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NCT01950364 · OUTCOME

Number of Participants With Markedly Abnormal Laboratory Values

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma · Source last updated 2016-05-11

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
Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)

What was measured

The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

Analysis population: Safety analysis set included all participants who received at least 1 dose of study drug.

Groups in this outcome

Brentuximab Vedotin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.

Brentuximab Vedotin + Rifampicin

Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.

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 Vedotin10
Brentuximab Vedotin + Rifampicin10

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Brentuximab Vedotin5Not reportedNot reportedNot reportedNot reported
Brentuximab Vedotin + Rifampicin5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    units
    Participants
description
The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
groups
  1. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
    id
    OG000
    title
    Brentuximab Vedotin
  2. description
    Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
    id
    OG001
    title
    Brentuximab Vedotin + Rifampicin
param Type
NUMBER
population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
title
Number of Participants With Markedly Abnormal Laboratory Values
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice