NCT01311687 · OUTCOME
Change From Baseline in the European Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status 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 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 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.
Analysis population: The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point are included.
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 | 209 |
|---|
| 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 | 0.52 | 23.01 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -3.75 | 24.10 | Not reported | Not reported | Not reported |
|---|
Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 175 |
|---|
| 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 | 2.67 | 24.97 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -2.36 | 21.08 | Not reported | Not reported | Not reported |
|---|
Cycle 4, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 157 |
|---|
| 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 | 0.80 | 24.62 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -3.03 | 22.42 | Not reported | Not reported | Not reported |
|---|
Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 130 |
|---|
| 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 | 0.51 | 26.81 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | 0.00 | 27.44 | Not reported | Not reported | Not reported |
|---|
Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Pomalidomide Plus Low-Dose Dexamethasone | 116 |
|---|
| 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 | -2.51 | 25.57 | Not reported | Not reported | Not reported |
|---|
| High-Dose Dexamethasone | -0.93 | 17.59 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.01
- value
- 0.52
- group Id
- OG001
- spread
- 24.10
- value
- -3.75
- denoms
- counts
- group Id
- OG000
- value
- 209
- group Id
- OG001
- value
- 91
- units
- Participants
- title
- Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 24.97
- value
- 2.67
- group Id
- OG001
- spread
- 21.08
- value
- -2.36
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 24.62
- value
- 0.80
- group Id
- OG001
- spread
- 22.42
- value
- -3.03
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 33
- units
- Participants
- title
- Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 26.81
- value
- 0.51
- group Id
- OG001
- spread
- 27.44
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Cycle 5 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 25.57
- value
- -2.51
- group Id
- OG001
- spread
- 17.59
- value
- -0.93
- denoms
- counts
- group Id
- OG000
- value
- 116
- 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 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 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or 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
- The Patient Reported Outcomes (PRO) study population includes any intent-to-treat study participants with 1 active treatment and 1 PRO measurement item completed. Only participants with available data at Baseline and each time point are included.
- 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 Organization for Research and Treatment of Cancer Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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