NCT01311687 · OUTCOME
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
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
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. 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 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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 | 210 |
|---|
| High-Dose Dexamethasone | 91 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | -2.32 | 18.25 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -3.96 | 18.35 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 177 |
|---|
| High-Dose Dexamethasone | 53 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | -0.56 | 19.86 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -9.69 | 16.67 | Not reported | Not reported | Not reported |
|---|
Cycle 4, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 159 |
|---|
| 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 | 0.17 | 20.25 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -8.08 | 13.31 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 132 |
|---|
| High-Dose Dexamethasone | 27 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 0.91 | 19.92 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -5.43 | 19.31 | Not reported | Not reported | Not reported |
|---|
Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 118 |
|---|
| 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 | 0.54 | 21.30 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -4.81 | 14.24 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.25
- value
- -2.32
- group Id
- OG001
- spread
- 18.35
- value
- -3.96
- denoms
- counts
- group Id
- OG000
- value
- 210
- group Id
- OG001
- value
- 91
- units
- Participants
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.86
- value
- -0.56
- group Id
- OG001
- spread
- 16.67
- value
- -9.69
- denoms
- counts
- group Id
- OG000
- value
- 177
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 20.25
- value
- 0.17
- group Id
- OG001
- spread
- 13.31
- value
- -8.08
- denoms
- counts
- group Id
- OG000
- value
- 159
- group Id
- OG001
- value
- 33
- units
- Participants
- title
- Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.92
- value
- 0.91
- group Id
- OG001
- spread
- 19.31
- value
- -5.43
- denoms
- counts
- group Id
- OG000
- value
- 132
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 21.30
- value
- 0.54
- group Id
- OG001
- spread
- 14.24
- value
- -4.81
- denoms
- counts
- group Id
- OG000
- value
- 118
- 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
- The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. 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 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
- 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 EORTC QLQ-C30 Physical Functioning Domain
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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