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NCT01564537 · OUTCOME

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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, EOT and follow-up (up to approximately 97 months)

What was measured

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems.

Analysis population: ITT population included all randomized participants. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.

Groups in this outcome

Ixazomib+ Lenalidomide + Dexamethasone

Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).

Placebo + Lenalidomide + Dexamethasone

Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

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
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Reported measurements

Global Health Index: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	355
Placebo + Lenalidomide + Dexamethasone	359

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	58.4	22.60	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	56.4	22.12	Not reported	Not reported	Not reported

Global Health Index: End of Treatment

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	251
Placebo + Lenalidomide + Dexamethasone	255

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-6.0	24.6	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-6.0	23.85	Not reported	Not reported	Not reported

Global Health Index: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	16.7	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Physical Functioning: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	359

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	70.0	21.74	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	67.3	23.54	Not reported	Not reported	Not reported

Physical Functioning: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	253
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-4.7	22.61	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-6.2	23.36	Not reported	Not reported	Not reported

Physical Functioning: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Role Functioning: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	68.4	28.75	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	64.4	30.24	Not reported	Not reported	Not reported

Role Functioning: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	253
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-8.6	31.27	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-8.6	32.90	Not reported	Not reported	Not reported

Role Functioning: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	-16.7	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Emotional Functioning: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	355
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	75.1	23.47	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	75.3	22.22	Not reported	Not reported	Not reported

Emotional Functioning: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	251
Placebo + Lenalidomide + Dexamethasone	256

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-2.1	20.09	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-6.1	23.16	Not reported	Not reported	Not reported

Emotional Functioning: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	-25.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Cognitive Functioning: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	355
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	81.9	20.42	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	81.6	19.79	Not reported	Not reported	Not reported

Cognitive Functioning: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	251
Placebo + Lenalidomide + Dexamethasone	256

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-7.6	20.61	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-5.8	22.24	Not reported	Not reported	Not reported

Cognitive Functioning: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	-50.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Social Functioning: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	354
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	77.9	26.07	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	75.3	26.47	Not reported	Not reported	Not reported

Social Functioning: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	250
Placebo + Lenalidomide + Dexamethasone	256

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-6.9	29.44	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-7.9	29.37	Not reported	Not reported	Not reported

Social Functioning: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Fatigue: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	38.4	23.98	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	39.5	25.14	Not reported	Not reported	Not reported

Fatigue: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	253
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	6.0	25.38	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	6.7	26.61	Not reported	Not reported	Not reported

Fatigue: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	22.2	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Pain: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	38.0	28.30	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	38.5	30.99	Not reported	Not reported	Not reported

Pain: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	253
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	2.7	26.65	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	3.8	30.07	Not reported	Not reported	Not reported

Pain: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Nausea and Vomiting: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	5.0	12.89	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	6.0	13.31	Not reported	Not reported	Not reported

Nausea and Vomiting: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	252
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	3.4	16.85	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	0.6	19.22	Not reported	Not reported	Not reported

Nausea and Vomiting: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	33.3	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Dyspnea: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	21.2	26.74	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	23.7	26.68	Not reported	Not reported	Not reported

Dyspnea: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	252
Placebo + Lenalidomide + Dexamethasone	261

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	5.7	31.04	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	2.3	27.33	Not reported	Not reported	Not reported

Dyspnea: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Insomnia: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	27.4	31.04	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	30.5	31.59	Not reported	Not reported	Not reported

Insomnia: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	252
Placebo + Lenalidomide + Dexamethasone	260

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	0.9	31.41	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	-0.5	33.26	Not reported	Not reported	Not reported

Insomnia: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	33.3	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Appetite Loss: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	356
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	16.9	25.70	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	15.3	25.21	Not reported	Not reported	Not reported

Appetite Loss: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	253
Placebo + Lenalidomide + Dexamethasone	260

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	4.7	31.49	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	6.5	28.47	Not reported	Not reported	Not reported

Appetite Loss: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Constipation: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	355
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	12.2	22.58	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	13.5	24.30	Not reported	Not reported	Not reported

Constipation: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	249
Placebo + Lenalidomide + Dexamethasone	259

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	-1.3	26.57	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	2.2	27.05	Not reported	Not reported	Not reported

Constipation: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	33.3	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Diarrhea: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	355
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	6.3	16.38	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	8.1	18.49	Not reported	Not reported	Not reported

Diarrhea: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	250
Placebo + Lenalidomide + Dexamethasone	256

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	17.2	31.08	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	10.8	31.53	Not reported	Not reported	Not reported

Diarrhea: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	0.0	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Financial Difficulties: Baseline

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	352
Placebo + Lenalidomide + Dexamethasone	360

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	16.7	26.15	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	18.6	28.30	Not reported	Not reported	Not reported

Financial Difficulties: EOT

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	250
Placebo + Lenalidomide + Dexamethasone	256

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Ixazomib+ Lenalidomide + Dexamethasone	0.5	20.69	Not reported	Not reported	Not reported
Placebo + Lenalidomide + Dexamethasone	1.3	26.54	Not reported	Not reported	Not reported

Financial Difficulties: Last Follow-up

Analysis denominator · Participants

Group	Source count
Ixazomib+ Lenalidomide + Dexamethasone	0
Placebo + Lenalidomide + Dexamethasone	1

Values in score on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo + Lenalidomide + Dexamethasone	-33.3	NA	Not reported	Not reported	The SD was not estimable due to single participant with event.

Complete source fields

classes

categories
measurements
group Id
OG000
spread
22.60
value
58.4
group Id
OG001
spread
22.12
value
56.4
denoms
counts
group Id
OG000
value
355
group Id
OG001
value
359
units
Participants
title
Global Health Index: Baseline
categories
measurements
group Id
OG000
spread
24.6
value
-6.0
group Id
OG001
spread
23.85
value
-6.0
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
255
units
Participants
title
Global Health Index: End of Treatment
categories
measurements
comment
The SD was not estimable due to single participant with event.
group Id
OG001
spread
NA
value
16.7
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
units
Participants
title
Global Health Index: Last Follow-up
categories
measurements
group Id
OG000
spread
21.74
value
70.0
group Id
OG001
spread
23.54
value
67.3
denoms
counts
group Id
OG000
value
356
group Id
OG001
value
359
units
Participants
title
Physical Functioning: Baseline
categories
measurements
group Id
OG000
spread
22.61
value
-4.7
group Id
OG001
spread
23.36
value
-6.2
denoms
counts
group Id
OG000
value
253
group Id
OG001
value
261
units
Participants
title
Physical Functioning: EOT
categories
measurements
comment
The SD was not estimable due to single participant with event.
group Id
OG001
spread
NA
value
0.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
units
Participants
title
Physical Functioning: Last Follow-up
categories
measurements
group Id
OG000
spread
28.75
value
68.4
group Id
OG001
spread
30.24
value
64.4
denoms
counts
group Id
OG000
value
356
group Id
OG001
value
360
units
Participants
title
Role Functioning: Baseline
categories
measurements
group Id
OG000
spread
31.27
value
-8.6
group Id
OG001
spread
32.90
value
-8.6
denoms
counts
group Id
OG000
value
253
group Id
OG001
value
261
units
Participants
title
Role Functioning: EOT
categories
measurements
comment
The SD was not estimable due to single participant with event.
group Id
OG001
spread
NA
value
-16.7
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
units
Participants
title
Role Functioning: Last Follow-up
categories
measurements
group Id
OG000
spread
23.47
value
75.1
group Id
OG001
spread
22.22
value
75.3
denoms
counts
group Id
OG000
value
355
group Id
OG001
value
360
units
Participants
title
Emotional Functioning: Baseline
categories
measurements
group Id
OG000
spread
20.09
value
-2.1
group Id
OG001
spread
23.16
value
-6.1
denoms
counts
group Id
OG000
value
251
group Id
OG001
value
256
units
Participants
title
Emotional Functioning: EOT
categories
measurements
comment
The SD was not estimable due to single participant with event.
group Id
OG001
spread
NA
value
-25.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
units
Participants
title
Emotional Functioning: Last Follow-up

denoms

counts
group Id
OG000
value
356
group Id
OG001
value
360
units
Participants

description

The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).The EORTC-QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems.

dispersion Type

Standard Deviation

groups

description
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
id
OG000
title
Ixazomib+ Lenalidomide + Dexamethasone
description
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
id
OG001
title
Placebo + Lenalidomide + Dexamethasone

param Type

MEAN

population Description

ITT population included all randomized participants. Overall number analyzed is the number of participants available for analysis. Number analyzed is the number of participants available for analysis at the given timepoint.

reporting Status

POSTED

time Frame

Baseline, EOT and follow-up (up to approximately 97 months)

title

Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) Questionnaire (EORTC-QLQ-C30)

type

SECONDARY

unit Of Measure

score on a scale

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

Preserved source evidence · Not medical advice