NCT00416624 · OUTCOME
Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
Epoetin Alfa or Darbepoetin Alfa in Treating Patients With Anemia Caused by Chemotherapy · Source last updated 2017-02-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Weeks 4, 7, 10, 13 and 16
What was measured
To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.
Analysis population: All patients that were evaluable per protocol with QOL data.
Groups in this outcome
Epoetin Alfa - 40k Weekly
Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
Epoetin Alfa - 80k Every 3 Weeks
Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Epoetin Alfa - 120k Every 3 Weeks
Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
Darbepoetin Alfa - 500 mcg Every 3 Weeks
Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
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 |
|---|
| Epoetin Alfa - 40k Weekly | 61 |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 60 |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 58 |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 57 |
|---|
Reported measurements
Overall QOL
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 6.4 | 1.59 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 6.5 | 2.00 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 6.6 | 2.17 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 6.1 | 1.61 | Not reported | Not reported | Not reported |
|---|
Mental QOL
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 6.9 | 1.80 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 7.0 | 1.97 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 7.2 | 1.91 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 6.5 | 1.39 | Not reported | Not reported | Not reported |
|---|
Physical QOL
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 5.7 | 1.54 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 5.8 | 2.11 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 5.9 | 2.22 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 5.8 | 1.65 | Not reported | Not reported | Not reported |
|---|
Emotional QOL
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 6.5 | 1.68 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 6.8 | 1.99 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 6.7 | 2.03 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 6.3 | 1.80 | Not reported | Not reported | Not reported |
|---|
Social Activity Level
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 5.5 | 2.08 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 5.5 | 2.12 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 5.4 | 2.34 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 5.1 | 2.01 | Not reported | Not reported | Not reported |
|---|
Spiritual QOL
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 7.4 | 1.54 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 7.4 | 1.81 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 7.3 | 2.07 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 6.8 | 1.99 | Not reported | Not reported | Not reported |
|---|
Pain Frequency
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 4.5 | 2.46 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 4.3 | 2.96 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 3.9 | 3.02 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 4.2 | 2.42 | Not reported | Not reported | Not reported |
|---|
Pain Severity
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 4.1 | 2.16 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 3.8 | 2.72 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 3.7 | 2.88 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 4.0 | 2.24 | Not reported | Not reported | Not reported |
|---|
Fatigue
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 5.6 | 1.59 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 5.5 | 2.02 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 5.6 | 2.14 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 5.4 | 1.60 | Not reported | Not reported | Not reported |
|---|
Anxiety
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Epoetin Alfa - 40k Weekly | 4.1 | 1.81 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 80k Every 3 Weeks | 3.9 | 2.20 | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa - 120k Every 3 Weeks | 4.6 | 2.36 | Not reported | Not reported | Not reported |
|---|
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 4.2 | 1.67 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.59
- value
- 6.4
- group Id
- OG001
- spread
- 2.00
- value
- 6.5
- group Id
- OG002
- spread
- 2.17
- value
- 6.6
- group Id
- OG003
- spread
- 1.61
- value
- 6.1
- title
- Overall QOL
- categories
- measurements
- group Id
- OG000
- spread
- 1.80
- value
- 6.9
- group Id
- OG001
- spread
- 1.97
- value
- 7.0
- group Id
- OG002
- spread
- 1.91
- value
- 7.2
- group Id
- OG003
- spread
- 1.39
- value
- 6.5
- title
- Mental QOL
- categories
- measurements
- group Id
- OG000
- spread
- 1.54
- value
- 5.7
- group Id
- OG001
- spread
- 2.11
- value
- 5.8
- group Id
- OG002
- spread
- 2.22
- value
- 5.9
- group Id
- OG003
- spread
- 1.65
- value
- 5.8
- title
- Physical QOL
- categories
- measurements
- group Id
- OG000
- spread
- 1.68
- value
- 6.5
- group Id
- OG001
- spread
- 1.99
- value
- 6.8
- group Id
- OG002
- spread
- 2.03
- value
- 6.7
- group Id
- OG003
- spread
- 1.80
- value
- 6.3
- title
- Emotional QOL
- categories
- measurements
- group Id
- OG000
- spread
- 2.08
- value
- 5.5
- group Id
- OG001
- spread
- 2.12
- value
- 5.5
- group Id
- OG002
- spread
- 2.34
- value
- 5.4
- group Id
- OG003
- spread
- 2.01
- value
- 5.1
- title
- Social Activity Level
- categories
- measurements
- group Id
- OG000
- spread
- 1.54
- value
- 7.4
- group Id
- OG001
- spread
- 1.81
- value
- 7.4
- group Id
- OG002
- spread
- 2.07
- value
- 7.3
- group Id
- OG003
- spread
- 1.99
- value
- 6.8
- title
- Spiritual QOL
- categories
- measurements
- group Id
- OG000
- spread
- 2.46
- value
- 4.5
- group Id
- OG001
- spread
- 2.96
- value
- 4.3
- group Id
- OG002
- spread
- 3.02
- value
- 3.9
- group Id
- OG003
- spread
- 2.42
- value
- 4.2
- title
- Pain Frequency
- categories
- measurements
- group Id
- OG000
- spread
- 2.16
- value
- 4.1
- group Id
- OG001
- spread
- 2.72
- value
- 3.8
- group Id
- OG002
- spread
- 2.88
- value
- 3.7
- group Id
- OG003
- spread
- 2.24
- value
- 4.0
- title
- Pain Severity
- categories
- measurements
- group Id
- OG000
- spread
- 1.59
- value
- 5.6
- group Id
- OG001
- spread
- 2.02
- value
- 5.5
- group Id
- OG002
- spread
- 2.14
- value
- 5.6
- group Id
- OG003
- spread
- 1.60
- value
- 5.4
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 1.81
- value
- 4.1
- group Id
- OG001
- spread
- 2.20
- value
- 3.9
- group Id
- OG002
- spread
- 2.36
- value
- 4.6
- group Id
- OG003
- spread
- 1.67
- value
- 4.2
- title
- Anxiety
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 58
- group Id
- OG003
- value
- 57
- units
- Participants
- description
- To compare the effects of the 3 different epoetin alfa dosing schedules and a darbepoetin alfa schedule. Linear Analogue Self Assessment (LASA) consists of 10 single-item numeric analogue scales on a scale of 0 to 10. Higher scores indicate better quality of life (QOL) on overall QOL, mental, physical, emotional spiritual QOL and Social activity; and constant pain, highest pain severity, level of fatigue and anxiety. Average scores across all time points for each item were calculated.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
- id
- OG000
- title
- Epoetin Alfa - 40k Weekly
- description
- Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
- id
- OG001
- title
- Epoetin Alfa - 80k Every 3 Weeks
- description
- Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
- id
- OG002
- title
- Epoetin Alfa - 120k Every 3 Weeks
- description
- Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
- id
- OG003
- title
- Darbepoetin Alfa - 500 mcg Every 3 Weeks
- param Type
- MEAN
- population Description
- All patients that were evaluable per protocol with QOL data.
- reporting Status
- POSTED
- time Frame
- Weeks 4, 7, 10, 13 and 16
- title
- Quality of Life as Measured by Linear Analogue Self Assessment Over All Follow-up Evaluation
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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