NCT04101331 · OUTCOME

Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)

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: nanogram*hour/milliliter
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 1 and Day 29.

What was measured

Area under concentration (AUC) versus time curve of the AFM13 in serum over time interval from 0 extrapolated to infinity. 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

Group	Source count
Cohort A	18

Reported measurements

Cycle 1 - day 1

Analysis denominator · Participants

Group	Source count
Cohort A	18

Values in nanogram*hour/milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort A	612361	60.3	Not reported	Not reported	Not reported

Cycle 1 - day 29

Analysis denominator · Participants

Group	Source count
Cohort A	13

Values in nanogram*hour/milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Cohort A	749717	35	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
60.3
value
612361
denoms
counts
group Id
OG000
value
18
units
Participants
title
Cycle 1 - day 1
categories
measurements
group Id
OG000
spread
35
value
749717
denoms
counts
group Id
OG000
value
13
units
Participants
title
Cycle 1 - day 29

denoms

counts
group Id
OG000
value
18
units
Participants

description

Area under concentration (AUC) versus time curve of the AFM13 in serum over time interval from 0 extrapolated to infinity. Geometric coefficient of variation is given in percentages.

dispersion Type

Geometric Coefficient of Variation

groups

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 1 and Day 29.

title

Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)

type

SECONDARY

unit Of Measure

nanogram*hour/milliliter

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

Preserved source evidence · Not medical advice