NCT01829711 · OUTCOME

Area Under the Plasma Concentration-time Curve From Time Zero to 3 Hours (AUC0-3hr) Post End of Moxetumomab Pasudotox

Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia · Source last updated 2020-04-08

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

Measure: MEAN
Unit: ng*hr/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, and 3 hr post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

What was measured

The AUC0-3hr of moxetumomab pasudotox is reported.

Analysis population: The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.

Groups in this outcome

Moxetumomab Pasudotox 40 µg/kg

Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.

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
Moxetumomab Pasudotox 40 µg/kg	80

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	6

Values in ng*hr/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	869	200	Not reported	Not reported	Not reported

Cycle 1 Day 5

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	54

Values in ng*hr/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	856	370	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	37

Values in ng*hr/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	1030	333	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
200
value
869
denoms
counts
group Id
OG000
value
6
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
370
value
856
denoms
counts
group Id
OG000
value
54
units
Participants
title
Cycle 1 Day 5
categories
measurements
group Id
OG000
spread
333
value
1030
denoms
counts
group Id
OG000
value
37
units
Participants
title
Cycle 2 Day 1

denoms

counts
group Id
OG000
value
80
units
Participants

description

The AUC0-3hr of moxetumomab pasudotox is reported.

dispersion Type

Standard Deviation

groups

description
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
id
OG000
title
Moxetumomab Pasudotox 40 µg/kg

param Type

MEAN

population Description

The PK population included all participants who received at least 1 dose of moxetumomab pasudotox and provided at least 1 baseline and post-baseline concentration-time data point.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 (pre-dose; 5 mins and 3 hr post dose); Cycle 1 Day 5 (pre-dose; 5 mins, 1 hr, and 3 hr post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

title

Area Under the Plasma Concentration-time Curve From Time Zero to 3 Hours (AUC0-3hr) Post End of Moxetumomab Pasudotox

type

SECONDARY

unit Of Measure

ng*hr/mL

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

Preserved source evidence · Not medical advice