TriangleNCT02604433 · OUTCOME
Mean Change From Baseline in the Transfusion-dependent Quality of Life (TranQol) Questionnaire At Week 24
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: 4 weeks prior to Day 1; Treatment: Week 24
What was measured
The TranQol is a self-administered quality of life tool developed for beta-thalassemia patients. The adult self-report version used in this study, includes 36 questions assessed on a 5-point response, that are grouped into 5 domains (Physical Health, Emotional Health, Sexual Health, Family Functioning, School/Career Functioning). Scores are calculated according to specific scoring algorithms developed by the authors. Both individual domains score and the total score range from 0 (worst) to 100 (best). Total Score and Physical Health domain score are reported. Positive change from baseline values indicate improvement.
Analysis population: All randomized participants with an evaluable TranQoL 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 | 200 |
| Placebo + BSC | 94 |
Reported measurements
Physical Health Domain Score - Change from Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | -1.5 | 14.26 | Not reported | Not reported | Not reported |
| Placebo + BSC | -0.7 | 14.24 | Not reported | Not reported | Not reported |
Total Score - Change from Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Luspatercept + BSC | 0.8 | 11.56 | Not reported | Not reported | Not reported |
| Placebo + BSC | -0.4 | 11.62 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Physical Health Domain Score - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.666
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- Total Score - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.384
- 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 Health Domain Score - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.666
- p Value Comment
- Significance level of 0.050 for 2-sided tests.
- statistical Method
- t-test, 2 sided
- group Description
- Total Score - Change from Baseline at Week 24
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.384
- 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
- 14.26
- value
- -1.5
- group Id
- OG001
- spread
- 14.24
- value
- -0.7
- title
- Physical Health Domain Score - Change from Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 11.56
- value
- 0.8
- group Id
- OG001
- spread
- 11.62
- value
- -0.4
- title
- Total Score - Change from Baseline
- denoms
- counts
- group Id
- OG000
- value
- 200
- group Id
- OG001
- value
- 94
- units
- Participants
- description
- The TranQol is a self-administered quality of life tool developed for beta-thalassemia patients. The adult self-report version used in this study, includes 36 questions assessed on a 5-point response, that are grouped into 5 domains (Physical Health, Emotional Health, Sexual Health, Family Functioning, School/Career Functioning). Scores are calculated according to specific scoring algorithms developed by the authors. Both individual domains score and the total score range from 0 (worst) to 100 (best). Total Score and Physical Health domain score are reported. 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 TranQoL questionnaire at screening visit and at least one post-screening visit
- reporting Status
- POSTED
- time Frame
- Baseline: 4 weeks prior to Day 1; Treatment: Week 24
- title
- Mean Change From Baseline in the Transfusion-dependent Quality of Life (TranQol) Questionnaire At Week 24
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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Preserved source evidence · Not medical advice