NCT02610777 · OUTCOME

Number of Participants in the Safety Analysis Population With Clinically Significant Change From Baseline Values in Vital Signs Reported as TEAEs

An Efficacy and Safety Study of Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine in Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) and Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2022-09-19

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 date of first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)

What was measured

Vital signs assessments included diastolic and systolic blood pressure, heart rate, and body temperature.

Analysis population: Safety Population included all enrolled participants who receive at least 1 dose of any study drug azacitidine alone or pevonedistat + azacitidine.

Groups in this outcome

Azacitidine 75 mg/m^2

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2

Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).

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
Azacitidine 75 mg/m^2	62
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2	58

Reported measurements

Pyrexia

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine 75 mg/m^2	25	Not reported	Not reported	Not reported	Not reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2	22	Not reported	Not reported	Not reported	Not reported

Hypotension

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Azacitidine 75 mg/m^2	3	Not reported	Not reported	Not reported	Not reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2	6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
25
group Id
OG001
value
22
title
Pyrexia
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
title
Hypotension

denoms

counts
group Id
OG000
value
62
group Id
OG001
value
58
units
Participants

description

Vital signs assessments included diastolic and systolic blood pressure, heart rate, and body temperature.

groups

description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
OG000
title
Azacitidine 75 mg/m^2
description
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
id
OG001
title
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety Population included all enrolled participants who receive at least 1 dose of any study drug azacitidine alone or pevonedistat + azacitidine.

reporting Status

POSTED

time Frame

From date of first dose up to 30 days after administration of the last dose of any study drug (up to approximately 5 years)

title

Number of Participants in the Safety Analysis Population With Clinically Significant Change From Baseline Values in 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