NCT03268954 · OUTCOME

Kaplan-Meier Estimates of Six-Month Survival Rate

Pevonedistat Plus Azacitidine Versus Single-Agent Azacitidine as First-Line Treatment for Participants With Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML), or Low-Blast Acute Myelogenous Leukemia (AML) · Source last updated 2025-10-29

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

Measure: NUMBER
Unit: percentage probability
Interval / dispersion: 95% Confidence Interval
Time frame: Month 6

What was measured

Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of Month 6 from randomization are presented.

Analysis population: ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses.

Groups in this outcome

Azacitidine 75 mg/m^2

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

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

Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.

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	174
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2	174

Reported measurements

Source class 1

Values in percentage probability · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Azacitidine 75 mg/m^2	0.825	Not reported	0.767	0.869	Not reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2	0.810	Not reported	0.752	0.856	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.767
upper Limit
0.869
value
0.825
group Id
OG001
lower Limit
0.752
upper Limit
0.856
value
0.810

denoms

counts
group Id
OG000
value
174
group Id
OG001
value
174
units
Participants

description

Kaplan-Meier estimates for the probability (expressed as a percentage) of participants that survived at the end of Month 6 from randomization are presented.

dispersion Type

95% Confidence Interval

groups

description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9, in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
OG000
title
Azacitidine 75 mg/m^2
description
Participants were administered azacitidine 75 mg/m\^2 IV or SC injection on Days 1 to 5, Days 8 and 9 and pevonedistat 20 mg/m\^2 IV infusion, on Days 1, 3, and 5 in 28-day treatment cycles until disease progression or unacceptable toxicity or up to a maximum of 63 cycles.
id
OG001
title
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2

param Type

NUMBER

population Description

ITT Population included all participants who were randomized. Overall number analyzed is the number of participants with data available for analyses.

reporting Status

POSTED

time Frame

Month 6

title

Kaplan-Meier Estimates of Six-Month Survival Rate

type

SECONDARY

unit Of Measure

percentage probability

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

Preserved source evidence · Not medical advice