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NCT03268954 · OUTCOME

Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Day 30

What was measured

30-day mortality was defined as number of participants who died within 30 days from the first dose of study drug.

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

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

GroupSource count
Azacitidine 75 mg/m^2220
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2223

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^26Not reportedNot reportedNot reportedNot reported
Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      223
    units
    Participants
description
30-day mortality was defined as number of participants who died within 30 days from the first dose of study drug.
groups
  1. 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
  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
COUNT_OF_PARTICIPANTS
population Description
Safety Population included all enrolled participants who received at least 1 dose of azacitidine alone or pevonedistat + azacitidine.
reporting Status
POSTED
time Frame
Up to Day 30
title
Thirty-Day Mortality Reported as Number of Participants Who Died Up to Day 30
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice