Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02312258 · OUTCOME

Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)

What was measured

ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.

Analysis population: Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.

Groups in this outcome

Placebo

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo271
Ixazomib415

Reported measurements

Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Placebo271
Ixazomib415
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.36Not reportedNot reportedNot reported
Ixazomib-0.00.42Not reportedNot reportedNot reported
Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Placebo263
Ixazomib396
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.36Not reportedNot reportedNot reported
Ixazomib-0.00.42Not reportedNot reportedNot reported
Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Placebo251
Ixazomib379
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.39Not reportedNot reportedNot reported
Ixazomib-0.10.42Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Placebo235
Ixazomib355
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.44Not reportedNot reportedNot reported
Ixazomib-0.00.44Not reportedNot reportedNot reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Placebo219
Ixazomib332
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.46Not reportedNot reportedNot reported
Ixazomib-0.00.43Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Placebo204
Ixazomib305
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.49Not reportedNot reportedNot reported
Ixazomib-0.00.42Not reportedNot reportedNot reported
Cycle 8 Day 1

Analysis denominator · Participants

GroupSource count
Placebo188
Ixazomib287
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.10.48Not reportedNot reportedNot reported
Ixazomib-0.00.42Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Placebo175
Ixazomib279
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.10.47Not reportedNot reportedNot reported
Ixazomib-0.00.45Not reportedNot reportedNot reported
Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Placebo163
Ixazomib261
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.10.52Not reportedNot reportedNot reported
Ixazomib-0.00.47Not reportedNot reportedNot reported
Cycle 11 Day 1

Analysis denominator · Participants

GroupSource count
Placebo151
Ixazomib246
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.10.51Not reportedNot reportedNot reported
Ixazomib-0.00.43Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Placebo142
Ixazomib235
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.10.56Not reportedNot reportedNot reported
Ixazomib-0.00.43Not reportedNot reportedNot reported
Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Placebo129
Ixazomib219
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.54Not reportedNot reportedNot reported
Ixazomib-0.00.46Not reportedNot reportedNot reported
Cycle 14 Day 1

Analysis denominator · Participants

GroupSource count
Placebo115
Ixazomib204
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.53Not reportedNot reportedNot reported
Ixazomib-0.00.44Not reportedNot reportedNot reported
Cycle 15 Day 1

Analysis denominator · Participants

GroupSource count
Placebo104
Ixazomib185
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.53Not reportedNot reportedNot reported
Ixazomib-0.00.49Not reportedNot reportedNot reported
Cycle 16 Day 1

Analysis denominator · Participants

GroupSource count
Placebo96
Ixazomib177
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.51Not reportedNot reportedNot reported
Ixazomib-0.00.49Not reportedNot reportedNot reported
Cycle 17 Day 1

Analysis denominator · Participants

GroupSource count
Placebo84
Ixazomib164
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo-0.00.54Not reportedNot reportedNot reported
Ixazomib-0.00.50Not reportedNot reportedNot reported
Cycle 18 Day 1

Analysis denominator · Participants

GroupSource count
Placebo74
Ixazomib159
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.51Not reportedNot reportedNot reported
Ixazomib-0.00.51Not reportedNot reportedNot reported
Cycle 19 Day 1

Analysis denominator · Participants

GroupSource count
Placebo65
Ixazomib148
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.47Not reportedNot reportedNot reported
Ixazomib-0.00.49Not reportedNot reportedNot reported
Cycle 20 Day 1

Analysis denominator · Participants

GroupSource count
Placebo57
Ixazomib133
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.46Not reportedNot reportedNot reported
Ixazomib-0.00.49Not reportedNot reportedNot reported
Cycle 21 Day 1

Analysis denominator · Participants

GroupSource count
Placebo52
Ixazomib122
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.48Not reportedNot reportedNot reported
Ixazomib-0.00.52Not reportedNot reportedNot reported
Cycle 22 Day 1

Analysis denominator · Participants

GroupSource count
Placebo51
Ixazomib111
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.10.51Not reportedNot reportedNot reported
Ixazomib-0.00.52Not reportedNot reportedNot reported
Cycle 23 Day 1

Analysis denominator · Participants

GroupSource count
Placebo42
Ixazomib101
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.44Not reportedNot reportedNot reported
Ixazomib-0.00.48Not reportedNot reportedNot reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Placebo41
Ixazomib91
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.10.54Not reportedNot reportedNot reported
Ixazomib-0.00.47Not reportedNot reportedNot reported
Cycle 25 Day 1

Analysis denominator · Participants

GroupSource count
Placebo35
Ixazomib79
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.42Not reportedNot reportedNot reported
Ixazomib-0.00.47Not reportedNot reportedNot reported
Cycle 26 Day 1

Analysis denominator · Participants

GroupSource count
Placebo28
Ixazomib68
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Placebo0.00.47Not reportedNot reportedNot reported
Ixazomib-0.00.47Not reportedNot reportedNot reported
PFSFU- Visit 37

Analysis denominator · Participants

GroupSource count
Placebo0
Ixazomib1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib1.0NANot reportedNot reportedStandard deviation was not estimable for a single participant.
PDFU- Visit 26

Analysis denominator · Participants

GroupSource count
Placebo0
Ixazomib1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ixazomib1.0NANot reportedNot reportedStandard deviation was not estimable for a single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.36
        value
        -0.0
      2. group Id
        OG001
        spread
        0.42
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        271
      2. group Id
        OG001
        value
        415
      units
      Participants
    title
    Cycle 2 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.36
        value
        -0.0
      2. group Id
        OG001
        spread
        0.42
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        263
      2. group Id
        OG001
        value
        396
      units
      Participants
    title
    Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.39
        value
        -0.0
      2. group Id
        OG001
        spread
        0.42
        value
        -0.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        251
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Cycle 4 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.44
        value
        -0.0
      2. group Id
        OG001
        spread
        0.44
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        235
      2. group Id
        OG001
        value
        355
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.46
        value
        -0.0
      2. group Id
        OG001
        spread
        0.43
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        219
      2. group Id
        OG001
        value
        332
      units
      Participants
    title
    Cycle 6 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.49
        value
        -0.0
      2. group Id
        OG001
        spread
        0.42
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        305
      units
      Participants
    title
    Cycle 7 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.48
        value
        -0.1
      2. group Id
        OG001
        spread
        0.42
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        188
      2. group Id
        OG001
        value
        287
      units
      Participants
    title
    Cycle 8 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.47
        value
        -0.1
      2. group Id
        OG001
        spread
        0.45
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        175
      2. group Id
        OG001
        value
        279
      units
      Participants
    title
    Cycle 9 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.52
        value
        -0.1
      2. group Id
        OG001
        spread
        0.47
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        163
      2. group Id
        OG001
        value
        261
      units
      Participants
    title
    Cycle 10 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.51
        value
        -0.1
      2. group Id
        OG001
        spread
        0.43
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        246
      units
      Participants
    title
    Cycle 11 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.56
        value
        -0.1
      2. group Id
        OG001
        spread
        0.43
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        142
      2. group Id
        OG001
        value
        235
      units
      Participants
    title
    Cycle 12 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.54
        value
        -0.0
      2. group Id
        OG001
        spread
        0.46
        value
        -0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        219
      units
      Participants
    title
    Cycle 13 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      271
    2. group Id
      OG001
      value
      415
    units
    Participants
description
ECOG performance status assesses a participant's performance status on a 6-point scale ranging from 0=fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead. Lower grades indicate improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    OG001
    title
    Ixazomib
param Type
MEAN
population Description
Safety Population included all participants who received at least 1 dose of ixazomib or placebo. Three placebo participants who erroneously received a single dose of ixazomib were included in the ixazomib arm of the safety population. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, and 26, progression free survival follow-up (PFSFU)- Visit 37 and progressive disease follow-up (PDFU)- Visit 26 (cycle length=28 days)
title
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice