TriangleNCT03170882 · OUTCOME
HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) 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 EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life.
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 QLQ-MY20 and 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 | 59.2 | 20.96 | Not reported | Not reported | Not reported |
| Ixazomib 4 mg + Dexamethasone 20 mg | 64.4 | 18.21 | Not reported | Not reported | Not reported |
End of Treatment
| Group | Source count |
|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 27 |
| Ixazomib 4 mg + Dexamethasone 20 mg | 41 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pomalidomide 4 mg + Dexamethasone 40 mg | 46.9 | 19.07 | Not reported | Not reported | Not reported |
| Ixazomib 4 mg + Dexamethasone 20 mg | 55.9 | 19.60 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.96
- value
- 59.2
- group Id
- OG001
- spread
- 18.21
- value
- 64.4
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 70
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 19.07
- value
- 46.9
- group Id
- OG001
- spread
- 19.60
- value
- 55.9
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 70
- units
- Participants
- description
- The EQ VAS records the respondent's self-rated health on a 20 centimeter (cm), vertical, visual analogue scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores from all dimensions were combined into a single index score that was reported, where higher score was better quality of life.
- 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 QLQ-MY20 and 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
- HRQOL Based on EuroQol Visual Analogue Scale (EQ VAS) Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice