Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score
A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20
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
End of Treatment (Up to 28 cycles, each cycle was of 28 days)
What was measured
EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions.
Analysis population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Overall number of participants analyzed are the number of participants with data available for analyses.
Groups in this outcome
Pomalidomide 4 mg + Dexamethasone 40 mg
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Ixazomib 4 mg + Dexamethasone 20 mg
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
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
Pomalidomide 4 mg + Dexamethasone 40 mg
27
Ixazomib 4 mg + Dexamethasone 20 mg
41
Reported measurements
Mobility: 1 = I Have no Problems in Walking About
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
5
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
9
Not reported
Not reported
Not reported
Not reported
Mobility: 2 = I Have Slight Problems in Walking About
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
12
Not reported
Not reported
Not reported
Not reported
Mobility: 3 = I Have Moderate Problems in Walking About
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
11
Not reported
Not reported
Not reported
Not reported
Mobility: 4 = I Have Severe Problems in Walking About
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
8
Not reported
Not reported
Not reported
Not reported
Mobility: 5 = I am Unable to Walk About
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
0
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
1
Not reported
Not reported
Not reported
Not reported
Self-Care: 1 = I Have no Problems Washing or Dressing Myself
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
13
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
21
Not reported
Not reported
Not reported
Not reported
Self-Care: 2 = I Have Slight Problems Washing or Dressing Myself
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
10
Not reported
Not reported
Not reported
Not reported
Self-Care: 3 = I Have Moderate Problems Washing or Dressing Myself
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
5
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
4
Not reported
Not reported
Not reported
Not reported
Self-Care: 4 = I Have Severe Problems Washing or Dressing Myself
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
3
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
4
Not reported
Not reported
Not reported
Not reported
Self-Care: 5 = I am Unable to Wash or Dress Myself
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
0
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
2
Not reported
Not reported
Not reported
Not reported
Usual Activities: 1 = I Have no Problems Doing my Usual Activities
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
4
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
10
Not reported
Not reported
Not reported
Not reported
Usual Activities: 2 = I Have Slight Problems Doing my Usual Activities
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
7
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
9
Not reported
Not reported
Not reported
Not reported
Usual Activities: 3 = I Have Moderate Problems Doing my Usual Activities
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
12
Not reported
Not reported
Not reported
Not reported
Usual Activities: 4 = I Have Severe Problems Doing my Usual Activities
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
7
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
7
Not reported
Not reported
Not reported
Not reported
Usual Activities: 5 = I am Unable to do my Usual Activities
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
1
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
3
Not reported
Not reported
Not reported
Not reported
Pain/Discomfort: 1 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
3
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
8
Not reported
Not reported
Not reported
Not reported
Pain/Discomfort: 2 = I Have Slight Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
5
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
10
Not reported
Not reported
Not reported
Not reported
Pain/Discomfort: 3 = I Have Moderate Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
13
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
15
Not reported
Not reported
Not reported
Not reported
Pain/Discomfort: 4 = I Have Severe Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
6
Not reported
Not reported
Not reported
Not reported
Pain/Discomfort: 5 = I Have Extreme Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
0
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
2
Not reported
Not reported
Not reported
Not reported
Anxiety/Depression: 1 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
6
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
19
Not reported
Not reported
Not reported
Not reported
Anxiety/Depression: 2 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
8
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
13
Not reported
Not reported
Not reported
Not reported
Anxiety/Depression: 3 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
11
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
6
Not reported
Not reported
Not reported
Not reported
Anxiety/Depression: 4 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
2
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
1
Not reported
Not reported
Not reported
Not reported
Anxiety/Depression: 5 = I Have no Pain or Discomfort
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
0
Not reported
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
9
title
Mobility: 1 = I Have no Problems in Walking About
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
12
title
Mobility: 2 = I Have Slight Problems in Walking About
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
11
title
Mobility: 3 = I Have Moderate Problems in Walking About
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
8
title
Mobility: 4 = I Have Severe Problems in Walking About
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Mobility: 5 = I am Unable to Walk About
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
21
title
Self-Care: 1 = I Have no Problems Washing or Dressing Myself
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
10
title
Self-Care: 2 = I Have Slight Problems Washing or Dressing Myself
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
title
Self-Care: 3 = I Have Moderate Problems Washing or Dressing Myself
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
4
title
Self-Care: 4 = I Have Severe Problems Washing or Dressing Myself
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Self-Care: 5 = I am Unable to Wash or Dress Myself
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
10
title
Usual Activities: 1 = I Have no Problems Doing my Usual Activities
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
9
title
Usual Activities: 2 = I Have Slight Problems Doing my Usual Activities
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
41
units
Participants
description
EQ-5D-5L comprises of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, 5= extremely severe problems. Higher scores indicated greater levels of problems across the five dimensions.
groups
description
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG000
title
Pomalidomide 4 mg + Dexamethasone 40 mg
description
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG001
title
Ixazomib 4 mg + Dexamethasone 20 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Overall number of participants analyzed are the number of participants with data available for analyses.
reporting Status
POSTED
time Frame
End of Treatment (Up to 28 cycles, each cycle was of 28 days)
title
Number of Participants With Responses to HRQOL Based on 5-level Classification System of the EuroQol 5-Dimensional Health Questionnaire (EQ-5D-5L) Score
Triangle