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NCT02610777 · OUTCOME

Number of Participants With Change From Baseline Values in Eastern Cooperative Oncology Group (ECOG) Performance Status

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

Number of participants with change from Baseline in ECOG performance status was measured on 6 point scale to assess participant's performance status, where: Grade 0(Normal activity. Fully active, able to carry on all pre-disease activities without restriction); Grade 1(Symptoms but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work); Grade 2(In bed \<50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours); Grade 3(In bed \>50% of the time. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours); Grade 4(100% bedridden. Completely disabled, cannot carry on any self-care, totally confined to bed or chair); Grade 5(Dead).

Analysis population: ITT population was defined as all participants who were randomized in the Safety Population. Only categories for which there was at least 1 participant are reported.

Groups in this outcome

Azacitidine 75 mg/m^2

Azacitidine 75 milligram per square meter (mg/m\^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on 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 Days 1 to 5, and on 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

Baseline: 0; Overall: 0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^213Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^29Not reportedNot reportedNot reportedNot reported
Baseline: 0; Overall: 1
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^213Not reportedNot reportedNot reportedNot reported
Baseline: 0; Overall: 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^23Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^23Not reportedNot reportedNot reportedNot reported
Baseline: 0; Overall: 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^20Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^22Not reportedNot reportedNot reportedNot reported
Baseline: 0; Overall: 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^22Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^20Not reportedNot reportedNot reportedNot reported
Baseline: 1; Overall: 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^217Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^218Not reportedNot reportedNot reportedNot reported
Baseline: 1; Overall: 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^28Not reportedNot reportedNot reportedNot reported
Baseline: 1; Overall: 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^25Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^22Not reportedNot reportedNot reportedNot reported
Baseline: 2; Overall: 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Azacitidine 75 mg/m^22Not reportedNot reportedNot reportedNot reported
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        9
    title
    Baseline: 0; Overall: 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        13
    title
    Baseline: 0; Overall: 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
    title
    Baseline: 0; Overall: 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Baseline: 0; Overall: 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Baseline: 0; Overall: 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        18
    title
    Baseline: 1; Overall: 1
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
    title
    Baseline: 1; Overall: 2
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Baseline: 1; Overall: 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Baseline: 2; Overall: 2
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      58
    units
    Participants
description
Number of participants with change from Baseline in ECOG performance status was measured on 6 point scale to assess participant's performance status, where: Grade 0(Normal activity. Fully active, able to carry on all pre-disease activities without restriction); Grade 1(Symptoms but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work); Grade 2(In bed \<50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours); Grade 3(In bed \>50% of the time. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours); Grade 4(100% bedridden. Completely disabled, cannot carry on any self-care, totally confined to bed or chair); Grade 5(Dead).
groups
  1. description
    Azacitidine 75 milligram per square meter (mg/m\^2), infusion, intravenously or subcutaneously, on Days 1 to 5, and on 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 Days 1 to 5, and on 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
ITT population was defined as all participants who were randomized in the Safety Population. Only categories for which there was at least 1 participant are reported.
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 With Change From Baseline Values in Eastern Cooperative Oncology Group (ECOG) Performance Status
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice