TriangleNCT02604433 · OUTCOME
Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire At Weeks 24
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- T-score
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24
What was measured
The SF-36 (version 2) is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. The raw score for each health domain is transformed into a 0 (worst) to 100 (best) domain score. The 0-100 scale score for each health domain is further converted to normbased scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL. The domains/summaries reported are: 1. Physical Functioning (Range of possible T-scores is 19.26 - 57.54) 2. General Health (Range of possible T-scores is 18.95 - 66.50) 3. Physical Component summary (PCS) (Range of possible T-scores is 5.02 - 79.78). Positive change from baseline values indicate improvement.
Analysis population: All randomized participants with an evaluable SF-36 questionnaire at screening visit and at least one post-screening visit
Groups in this outcome
Luspatercept + BSC
Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
Placebo + BSC
Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
| Group | Source count |
|---|---|
| Luspatercept + BSC | 210 |
| Placebo + BSC | 103 |
Reported measurements
Physical Functioning Domain Score - Change from Baseline
| Group | Source count |
|---|---|
| Luspatercept + BSC | 197 |
| Placebo + BSC | 91 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | -0.3 | 6.93 | Not reported | Not reported | Not reported |
| Placebo + BSC | -0.2 | 7.86 | Not reported | Not reported | Not reported |
General Health Domain Score - Change from Baseline
| Group | Source count |
|---|---|
| Luspatercept + BSC | 197 |
| Placebo + BSC | 91 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 0.4 | 7.18 | Not reported | Not reported | Not reported |
| Placebo + BSC | 0.3 | 7.03 | Not reported | Not reported | Not reported |
PCS - Change from Baseline
| Group | Source count |
|---|---|
| Luspatercept + BSC | 197 |
| Placebo + BSC | 91 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | -0.4 | 7.01 | Not reported | Not reported | Not reported |
| Placebo + BSC | -0.3 | 7.97 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Physical Functioning Domain - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.918
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- General Health Domain - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.857
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- PCS - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.839
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
Complete source fields
- analyses
- group Description
- Physical Functioning Domain - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.918
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- General Health Domain - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.857
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- PCS - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.839
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.93
- value
- -0.3
- group Id
- OG001
- spread
- 7.86
- value
- -0.2
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 91
- units
- Participants
- title
- Physical Functioning Domain Score - Change from Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 7.18
- value
- 0.4
- group Id
- OG001
- spread
- 7.03
- value
- 0.3
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 91
- units
- Participants
- title
- General Health Domain Score - Change from Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 7.01
- value
- -0.4
- group Id
- OG001
- spread
- 7.97
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 197
- group Id
- OG001
- value
- 91
- units
- Participants
- title
- PCS - Change from Baseline
- denoms
- counts
- group Id
- OG000
- value
- 210
- group Id
- OG001
- value
- 103
- units
- Participants
- description
- The SF-36 (version 2) is a generic, self-administered instrument consisting of 8 multi-item scales that assess 8 health domains. The raw score for each health domain is transformed into a 0 (worst) to 100 (best) domain score. The 0-100 scale score for each health domain is further converted to normbased scores using a T-score transformation, with a mean of 50 and a standard deviation (SD) of 10. Higher norm-based T-scores indicate better heath/QoL. The domains/summaries reported are: 1. Physical Functioning (Range of possible T-scores is 19.26 - 57.54) 2. General Health (Range of possible T-scores is 18.95 - 66.50) 3. Physical Component summary (PCS) (Range of possible T-scores is 5.02 - 79.78). Positive change from baseline values indicate improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Luspatercept (ACE-536) was administered subcutaneously (SC) at a starting dose level of 1 mg/kg once every 21 days. Participants could be dose-titrated to 1.25 mg/kg, but the maximum total dose should not exceed 120 mg, total dose per administration during the Treatment Period, the Long-term Treatment Period, and Open-Label Treatment Period. BSC = Best Supportive Care
- id
- OG000
- title
- Luspatercept + BSC
- description
- Placebo (normal saline) was administered subcutaneously (SC) in volumes to match active treatment once every 21 days. BSC = Best Supportive Care
- id
- OG001
- title
- Placebo + BSC
- param Type
- MEAN
- population Description
- All randomized participants with an evaluable SF-36 questionnaire at screening visit and at least one post-screening visit
- reporting Status
- POSTED
- time Frame
- Baseline: 4 weeks prior to Day 1; Treatment: Weeks 24
- title
- Mean Change From Baseline in the 36-item Short Form Health Survey (SF-36) Questionnaire At Weeks 24
- type
- SECONDARY
- unit Of Measure
- T-score
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Preserved source evidence · Not medical advice