TriangleNCT01539083 · OUTCOME
Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
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
- Baseline, Month 12
What was measured
The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).
Analysis population: All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.
Groups in this outcome
Thalidomide + Prednisolone [TP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
| Group | Source count |
|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 83 |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 86 |
Reported measurements
Independent Living
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.15 | 0.335 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.14 | 0.397 | Not reported | Not reported | Not reported |
Relationships
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.06 | 0.300 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.05 | 0.296 | Not reported | Not reported | Not reported |
Mental Health
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.18 | 0.319 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.18 | 0.270 | Not reported | Not reported | Not reported |
Coping
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.08 | 0.278 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.05 | 0.237 | Not reported | Not reported | Not reported |
Pain
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.20 | 0.373 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.20 | 0.395 | Not reported | Not reported | Not reported |
Senses
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.03 | 0.140 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.00 | 0.137 | Not reported | Not reported | Not reported |
AQoL-6D Utility score
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Thalidomide + Prednisolone [TP Consolidation] | 0.11 | 0.216 | Not reported | Not reported | Not reported |
| Bortezomib + Thalidomide + Prednisolone [VTP Consolidation] | 0.11 | 0.213 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.335
- value
- 0.15
- group Id
- OG001
- spread
- 0.397
- value
- 0.14
- title
- Independent Living
- categories
- measurements
- group Id
- OG000
- spread
- 0.300
- value
- 0.06
- group Id
- OG001
- spread
- 0.296
- value
- 0.05
- title
- Relationships
- categories
- measurements
- group Id
- OG000
- spread
- 0.319
- value
- 0.18
- group Id
- OG001
- spread
- 0.270
- value
- 0.18
- title
- Mental Health
- categories
- measurements
- group Id
- OG000
- spread
- 0.278
- value
- 0.08
- group Id
- OG001
- spread
- 0.237
- value
- 0.05
- title
- Coping
- categories
- measurements
- group Id
- OG000
- spread
- 0.373
- value
- 0.20
- group Id
- OG001
- spread
- 0.395
- value
- 0.20
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 0.140
- value
- 0.03
- group Id
- OG001
- spread
- 0.137
- value
- 0.00
- title
- Senses
- categories
- measurements
- group Id
- OG000
- spread
- 0.216
- value
- 0.11
- group Id
- OG001
- spread
- 0.213
- value
- 0.11
- title
- AQoL-6D Utility score
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 86
- units
- Participants
- description
- The assessment of quality of life-6D (AQoL-6D) is a multi-attribute health-related quality of life instrument (QoL). It comprises dimension scores for independent living, relationships, mental health, coping, pain, senses, and utility score for AQol-6D. Each scale ranges between 1 (best QoL) and -0.04 (worst possible QoL).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG000
- title
- Thalidomide + Prednisolone [TP Consolidation]
- description
- Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m\^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
- id
- OG001
- title
- Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]
- param Type
- MEAN
- population Description
- All treated randomized analysis set was defined as participants in the all enrolled set (participants with non-missing informed consent date,not screen failures) received at least 1 dose of any study drug and randomized to receive consolidation treatment. Here, 'N'(number of participants analyzed) participants who were evaluable for this endpoint.
- reporting Status
- POSTED
- time Frame
- Baseline, Month 12
- title
- Consolidation Phase: Change From Baseline in AQOL-6D Scores at the End of the Consolidation Phase
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice