NCT01829711 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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/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, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

What was measured

The Cmax 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	75

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	192	162	Not reported	Not reported	Not reported

Cycle 1 Day 5

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	71

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	435	233	Not reported	Not reported	Not reported

Cycle 2 Day 1

Analysis denominator · Participants

Group	Source count
Moxetumomab Pasudotox 40 µg/kg	69

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	379	262	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
162
value
192
denoms
counts
group Id
OG000
value
75
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
233
value
435
denoms
counts
group Id
OG000
value
71
units
Participants
title
Cycle 1 Day 5
categories
measurements
group Id
OG000
spread
262
value
379
denoms
counts
group Id
OG000
value
69
units
Participants
title
Cycle 2 Day 1

denoms

counts
group Id
OG000
value
80
units
Participants

description

The Cmax 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, 3 hr, and 6 hrs post dose); and Cycle 2 Day 1 (pre-dose; 5 mins and 3 hr post dose)

title

Maximum Observed Plasma Concentration (Cmax) of Moxetumomab Pasudotox

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice