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NCT04101331 · OUTCOME

Volume of Distribution at Steady State (Vss) of AFM13

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides · Source last updated 2024-11-05

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

Measure
GEOMETRIC_MEAN
Unit
Liter
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29.

What was measured

Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.

Analysis population: The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.

Groups in this outcome

Cohort A

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

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

Analysis denominator · Participants

GroupSource count
Cohort A13

Reported measurements

Source class 1
Values in Liter · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Cohort A5.158.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        58.4
        value
        5.1
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Volume of distribution at steady state (Vss) of the AFM13. Geometric coefficient of variation is given in percentages.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
    id
    OG000
    title
    Cohort A
param Type
GEOMETRIC_MEAN
population Description
The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
reporting Status
POSTED
time Frame
Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 29.
title
Volume of Distribution at Steady State (Vss) of AFM13
type
SECONDARY
unit Of Measure
Liter

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

Preserved source evidence · Not medical advice