TriangleNCT00416624 · OUTCOME
Quality of Life as Measured by Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
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. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale 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 | 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
FACT Fatigue Concerns
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Epoetin Alfa - 40k Weekly | 48.6 | 17.13 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 80k Every 3 Weeks | 52.0 | 20.75 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 120k Every 3 Weeks | 52.6 | 23.12 | Not reported | Not reported | Not reported |
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 49.8 | 19.66 | Not reported | Not reported | Not reported |
FACT Nonfatigue Concerns
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Epoetin Alfa - 40k Weekly | 60.6 | 13.08 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 80k Every 3 Weeks | 62.2 | 16.64 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 120k Every 3 Weeks | 61.3 | 16.27 | Not reported | Not reported | Not reported |
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 59.4 | 13.39 | Not reported | Not reported | Not reported |
FACT Total Anemia
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Epoetin Alfa - 40k Weekly | 52.8 | 14.58 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 80k Every 3 Weeks | 55.6 | 18.08 | Not reported | Not reported | Not reported |
| Epoetin Alfa - 120k Every 3 Weeks | 55.6 | 19.85 | Not reported | Not reported | Not reported |
| Darbepoetin Alfa - 500 mcg Every 3 Weeks | 53.1 | 16.24 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 17.13
- value
- 48.6
- group Id
- OG001
- spread
- 20.75
- value
- 52.0
- group Id
- OG002
- spread
- 23.12
- value
- 52.6
- group Id
- OG003
- spread
- 19.66
- value
- 49.8
- title
- FACT Fatigue Concerns
- categories
- measurements
- group Id
- OG000
- spread
- 13.08
- value
- 60.6
- group Id
- OG001
- spread
- 16.64
- value
- 62.2
- group Id
- OG002
- spread
- 16.27
- value
- 61.3
- group Id
- OG003
- spread
- 13.39
- value
- 59.4
- title
- FACT Nonfatigue Concerns
- categories
- measurements
- group Id
- OG000
- spread
- 14.58
- value
- 52.8
- group Id
- OG001
- spread
- 18.08
- value
- 55.6
- group Id
- OG002
- spread
- 19.85
- value
- 55.6
- group Id
- OG003
- spread
- 16.24
- value
- 53.1
- title
- FACT Total Anemia
- 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. FACT-AN consist of Fatigue concerns subscale and non-fatigue concerns subscale. FACT Total Anemia score was calculated by adding the two subscales scores and transformed into 0-100 scale. FACT Total Anemia, Fatigue concerns scale and Non-Fatigue concerns scale are all ranges: 0 (Worst QOL) to 100 (Best QOL). Average scores across all time points for each subscale and total scale 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 Functional Assessment of Cancer Therapy Scales for Anemia (FACT-AN) Over All Follow-up Evaluations
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice