NCT01311687 · OUTCOME
Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score
A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
What was measured
EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals "perfect health", a score of 0 equals "death" and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL
Analysis population: PRO population with available data at Baseline and each time point.
Groups in this outcome
Pomalidomide Plus Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
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 Plus Low-Dose Dexamethasone | 289 |
|---|
| High-Dose Dexamethasone | 144 |
|---|
Reported measurements
Cycle 2, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 198 |
|---|
| High-Dose Dexamethasone | 89 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | -0.03 | 0.28 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.02 | 0.23 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 167 |
|---|
| High-Dose Dexamethasone | 52 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 0.01 | 0.29 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.06 | 0.27 | Not reported | Not reported | Not reported |
|---|
Cycle 4, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 146 |
|---|
| High-Dose Dexamethasone | 33 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 0.04 | 0.31 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.07 | 0.29 | Not reported | Not reported | Not reported |
|---|
Cycle 5, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 125 |
|---|
| High-Dose Dexamethasone | 25 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 0.01 | 0.32 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.04 | 0.26 | Not reported | Not reported | Not reported |
|---|
Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 108 |
|---|
| High-Dose Dexamethasone | 18 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 0.03 | 0.31 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.12 | 0.19 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.28
- value
- -0.03
- group Id
- OG001
- spread
- 0.23
- value
- -0.02
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 89
- units
- Participants
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.29
- value
- 0.01
- group Id
- OG001
- spread
- 0.27
- value
- -0.06
- denoms
- counts
- group Id
- OG000
- value
- 167
- group Id
- OG001
- value
- 52
- units
- Participants
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.31
- value
- 0.04
- group Id
- OG001
- spread
- 0.29
- value
- -0.07
- denoms
- counts
- group Id
- OG000
- value
- 146
- group Id
- OG001
- value
- 33
- units
- Participants
- title
- Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.32
- value
- 0.01
- group Id
- OG001
- spread
- 0.26
- value
- -0.04
- denoms
- counts
- group Id
- OG000
- value
- 125
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- Cycle 5, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.31
- value
- 0.03
- group Id
- OG001
- spread
- 0.19
- value
- -0.12
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- Cycle 6, Day 1
- denoms
- counts
- group Id
- OG000
- value
- 289
- group Id
- OG001
- value
- 144
- units
- Participants
- description
- EQ-5D is a self-administered questionnaire that assesses health-related quality of life (QOL). The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where an EQ-5D score of 1.00 equals "perfect health", a score of 0 equals "death" and a score of -0.59 equals worst imaginable health state. A positive change from Baseline score indicates improvement in health status. A negative change from Baseline score indicates worsening in health status. Negative scores represent the possible though unlikely situation that a patient's QOL is worse than death, i.e. they would rather be dead than living with that QOL
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
- id
- OG000
- title
- Pomalidomide Plus Low-Dose Dexamethasone
- description
- Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
- id
- OG001
- title
- High-Dose Dexamethasone
- param Type
- MEAN
- population Description
- PRO population with available data at Baseline and each time point.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
- title
- Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Utility Index Score
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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