TriangleNCT03170882 · OUTCOME
Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score
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 and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
What was measured
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning.
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 Multiple Myeloma Module 20 \[QLQ-MY20\] and EuroQol 5-Dimensional Health Questionnaire \[EQ-5D-5L\]). Number analyzed are the number of participants with data available for analyses at the given timepoint.
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 | Source count |
|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 45 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 70 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 45 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 70 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 67.0 | 21.97 | Not reported | Not reported | Not reported |
| Ixazomib 4 mg + Dexamethasone 20 mg | 67.9 | 22.08 | Not reported | Not reported | Not reported |
End of Treatment
| Group | Source count |
|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 28 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 42 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 52.4 | 28.03 | Not reported | Not reported | Not reported |
| Ixazomib 4 mg + Dexamethasone 20 mg | 56.5 | 26.10 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.97
- value
- 67.0
- group Id
- OG001
- spread
- 22.08
- value
- 67.9
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 70
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 28.03
- value
- 52.4
- group Id
- OG001
- spread
- 26.10
- value
- 56.5
- denoms
- counts
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 70
- units
- Participants
- description
- The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/quality of life (QOL) scale. The physical domain consisted of 5 items covering participant's daily physical activities on a scale from 1 (not at all) to 4 (very much). Raw scores were linearly transformed to a total score between 0-100, with a high score indicating better physical functioning.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- 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 Multiple Myeloma Module 20 \[QLQ-MY20\] and EuroQol 5-Dimensional Health Questionnaire \[EQ-5D-5L\]). Number analyzed are the number of participants with data available for analyses at the given timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
- title
- Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 (EORTC QLQ-C30) Physical Domain Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice