NCT03361748 · OUTCOME
Mean Change From Baseline on the EORTC QLQ-C30 - Global Heath/QoL
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
Mean change from baseline on the EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL.
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 | 114 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | -4.7 | 17.03 | Not reported | Not reported | Not reported |
|---|
Month 1
Analysis denominator · Participants
| Group | Source count |
|---|
| BB2121 | 109 |
|---|
Values in Score on a Scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| BB2121 | 4.3 | 19.95 | 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 | 8.8 | 20.31 | 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 | 12.5 | 19.12 | 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 | 15.7 | 20.88 | 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 | 14.1 | 21.57 | 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 | 10.6 | 17.25 | 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 | 7.1 | 14.93 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.03
- value
- -4.7
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 19.95
- value
- 4.3
- title
- Month 1
- categories
- measurements
- group Id
- OG000
- spread
- 20.31
- value
- 8.8
- title
- Month 3
- categories
- measurements
- group Id
- OG000
- spread
- 19.12
- value
- 12.5
- title
- Month 6
- categories
- measurements
- group Id
- OG000
- spread
- 20.88
- value
- 15.7
- title
- Month 9
- categories
- measurements
- group Id
- OG000
- spread
- 21.57
- value
- 14.1
- title
- Month 12
- categories
- measurements
- group Id
- OG000
- spread
- 17.25
- value
- 10.6
- title
- Month 18
- categories
- measurements
- group Id
- OG000
- spread
- 14.93
- value
- 7.1
- title
- Month 24
- description
- Mean change from baseline on the EORTC QLQ-C30
The EORTC QLQ-C30 is a 30-item scale composed of both multi-item scales and single-item measures. All of the scales and single-item measures range in score from 0 to 100. A higher scale score represents a higher level of well-being and better ability of daily functioning. Thus, a high score for a functional scale represents a high/healthy level of functioning; a high score for the global health status/HRQoL represents a high HRQoL.
- 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 EORTC QLQ-C30 - Global Heath/QoL
- type
- SECONDARY
- unit Of Measure
- Score on a Scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice