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NCT02610777 · OUTCOME

Number of Participants in the Safety Analysis Population With Clinically Significant Laboratory Abnormalities 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

Laboratory assessments included clinical chemistry, hematology, and urinalysis.

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

GroupSource count
Azacitidine 75 mg/m^262
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^258

Reported measurements

Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^221Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^221Not reportedNot reportedNot reportedNot reported
Anaemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^229Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^219Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^26Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^212Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^215Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^216Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        21
    title
    Neutropenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        19
    title
    Anaemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        12
    title
    Neutrophil count decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        16
    title
    Thrombocytopenia
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      58
    units
    Participants
description
Laboratory assessments included clinical chemistry, hematology, and urinalysis.
groups
  1. 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
  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 Laboratory Abnormalities Reported as TEAEs
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice