NCT03682536 · OUTCOME
Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20
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, Day 1 on weeks 7,13,19, and 24.
What was measured
The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:
* Physical well-being (sum of 7 items, score range from 0-28)
* Social/Family well-being (sum of 7 items, score range from 0-28)
* Emotional well-being (sum of 6 items, score range from 0-24)
* Functional well-being (sum of 7 items, score range from 0-28)
* Anemia-related symptoms (sum of 20 items, score range from 0-80)
A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug.
Analysis population: All randomized participants who completed the Fact-An assessment at baseline and post-baseline assessment at the respective visit.
Groups in this outcome
Luspatercept
Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
Epoetin Alfa
Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
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 |
|---|
| Luspatercept | 145 |
|---|
| Epoetin Alfa | 133 |
|---|
Reported measurements
W7D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Luspatercept | 145 |
|---|
| Epoetin Alfa | 133 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 2.1 | 17.41 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 3.7 | 16.43 | Not reported | Not reported | Not reported |
|---|
W13D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Luspatercept | 136 |
|---|
| Epoetin Alfa | 121 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 1.8 | 20.58 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 4.5 | 20.36 | Not reported | Not reported | Not reported |
|---|
W19D1
Analysis denominator · Participants
| Group | Source count |
|---|
| Luspatercept | 129 |
|---|
| Epoetin Alfa | 118 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | -0.2 | 19.30 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 3.1 | 23.07 | Not reported | Not reported | Not reported |
|---|
Week 24 (D169)
Analysis denominator · Participants
| Group | Source count |
|---|
| Luspatercept | 137 |
|---|
| Epoetin Alfa | 120 |
|---|
Values in Score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 1.5 | 21.39 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 2.8 | 22.18 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.41
- value
- 2.1
- group Id
- OG001
- spread
- 16.43
- value
- 3.7
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 133
- units
- Participants
- title
- W7D1
- categories
- measurements
- group Id
- OG000
- spread
- 20.58
- value
- 1.8
- group Id
- OG001
- spread
- 20.36
- value
- 4.5
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 121
- units
- Participants
- title
- W13D1
- categories
- measurements
- group Id
- OG000
- spread
- 19.30
- value
- -0.2
- group Id
- OG001
- spread
- 23.07
- value
- 3.1
- denoms
- counts
- group Id
- OG000
- value
- 129
- group Id
- OG001
- value
- 118
- units
- Participants
- title
- W19D1
- categories
- measurements
- group Id
- OG000
- spread
- 21.39
- value
- 1.5
- group Id
- OG001
- spread
- 22.18
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 137
- group Id
- OG001
- value
- 120
- units
- Participants
- title
- Week 24 (D169)
- denoms
- counts
- group Id
- OG000
- value
- 145
- group Id
- OG001
- value
- 133
- units
- Participants
- description
- The Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire includes 47 items rating on a 5-point Likert scale from 0 (not at all) to 4 (very much) (so that 0 is considered worse quality of life and 4 is good response) on five primary subscales:
* Physical well-being (sum of 7 items, score range from 0-28)
* Social/Family well-being (sum of 7 items, score range from 0-28)
* Emotional well-being (sum of 6 items, score range from 0-24)
* Functional well-being (sum of 7 items, score range from 0-28)
* Anemia-related symptoms (sum of 20 items, score range from 0-80)
A total score for the FACT-An can be calculated by summing the five primary subscales with a score range from 0-188. Higher scores representing better quality of life. Baseline is defined as the last value on or before the first dose of study drug.
- dispersion Type
- Standard Deviation
- groups
- description
- Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
- id
- OG000
- title
- Luspatercept
- description
- Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
- id
- OG001
- title
- Epoetin Alfa
- param Type
- MEAN
- population Description
- All randomized participants who completed the Fact-An assessment at baseline and post-baseline assessment at the respective visit.
- reporting Status
- POSTED
- time Frame
- Baseline, Day 1 on weeks 7,13,19, and 24.
- title
- Change From Baseline in the Functional Assessment of Cancer Therapy-Anemia Version 4 (FACT-An)
- type
- SECONDARY
- unit Of Measure
- Score on a scale
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