NCT03361748 · OUTCOME
Mean Change From Baseline on the EQ-5D-5L Index
Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2025-05-23
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
- At Day 1 and at specific time points up to month 24
What was measured
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.
Analysis population: PRO Analysis Set
Groups in this outcome
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 |
|---|
| BB2121 | 126 |
|---|
Reported measurements
Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 115 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.0314 | 0.1760 | Not reported | Not reported | Not reported |
|---|
Month 1
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 110 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.0528 | 0.2473 | Not reported | Not reported | Not reported |
|---|
Month 3
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 86 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.0998 | 0.1956 | Not reported | Not reported | Not reported |
|---|
Month 6
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 76 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.0974 | 0.1798 | Not reported | Not reported | Not reported |
|---|
Month 9
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 59 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.1067 | 0.2334 | Not reported | Not reported | Not reported |
|---|
Month 12
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 55 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.1097 | 0.2287 | Not reported | Not reported | Not reported |
|---|
Month 18
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 26 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.1101 | 0.2027 | Not reported | Not reported | Not reported |
|---|
Month 24
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 14 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 0.0383 | 0.1604 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.1760
- value
- 0.0314
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.2473
- value
- 0.0528
- title
- Month 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.1956
- value
- 0.0998
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- spread
- 0.1798
- value
- 0.0974
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- spread
- 0.2334
- value
- 0.1067
- title
- Month 9
- categories
- measurements
- group Id
- OG000
- spread
- 0.2287
- value
- 0.1097
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- spread
- 0.2027
- value
- 0.1101
- title
- Month 18
- categories
- measurements
- group Id
- OG000
- spread
- 0.1604
- value
- 0.0383
- title
- Month 24
- description
- The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.
- dispersion Type
- Standard Deviation
- groups
- description
- BB2121
- id
- OG000
- title
- BB2121
- param Type
- MEAN
- population Description
- PRO Analysis Set
- reporting Status
- POSTED
- time Frame
- At Day 1 and at specific time points up to month 24
- title
- Mean Change From Baseline on the EQ-5D-5L Index
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
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