NCT01829711 · OUTCOME

Number of Participants With Abnormal Vital Signs Reported as TEAEs

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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)

What was measured

An abnormal vital signs that were judged by the investigator to be medically significant were reported as AEs. The TEAEs are defined as AEs present at baseline that worsened in intensity after administration of study drug, or events absent at baseline that emerged after administration of study drug, up to 30 days after the last dose of study drug (approximately 7 months).

Analysis population: Safety population included participants who received at least 1 dose of moxetumomab pasudotox.

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

Dyspnoea

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	9	Not reported	Not reported	Not reported	Not reported

Dyspnoea exertional

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	3	Not reported	Not reported	Not reported	Not reported

Hypertension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	12	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	6	Not reported	Not reported	Not reported	Not reported

Pyrexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Moxetumomab Pasudotox 40 µg/kg	25	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
9
title
Dyspnoea
categories
measurements
group Id
OG000
value
3
title
Dyspnoea exertional
categories
measurements
group Id
OG000
value
12
title
Hypertension
categories
measurements
group Id
OG000
value
6
title
Hypotension
categories
measurements
group Id
OG000
value
25
title
Pyrexia

denoms

counts
group Id
OG000
value
80
units
Participants

description

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

COUNT_OF_PARTICIPANTS

population Description

Safety population included participants who received at least 1 dose of moxetumomab pasudotox.

reporting Status

POSTED

time Frame

From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months)

title

Number of Participants With Abnormal Vital Signs Reported as TEAEs

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice