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NCT00416624 · OUTCOME

Quality of Life as Measured by Brief Fatigue Inventory Overall All Follow-up Evaluations

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. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale 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

GroupSource count
Epoetin Alfa - 40k Weekly61
Epoetin Alfa - 80k Every 3 Weeks60
Epoetin Alfa - 120k Every 3 Weeks58
Darbepoetin Alfa - 500 mcg Every 3 Weeks57

Reported measurements

Fatigue Now
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly4.82.25Not reportedNot reportedNot reported
Epoetin Alfa - 80k Every 3 Weeks4.62.44Not reportedNot reportedNot reported
Epoetin Alfa - 120k Every 3 Weeks4.62.53Not reportedNot reportedNot reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks4.72.25Not reportedNot reportedNot reported
Usual Fatigue
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly4.72.12Not reportedNot reportedNot reported
Epoetin Alfa - 80k Every 3 Weeks4.72.40Not reportedNot reportedNot reported
Epoetin Alfa - 120k Every 3 Weeks4.72.53Not reportedNot reportedNot reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks4.72.24Not reportedNot reportedNot reported
Worst Fatigue
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly5.52.17Not reportedNot reportedNot reported
Epoetin Alfa - 80k Every 3 Weeks5.62.54Not reportedNot reportedNot reported
Epoetin Alfa - 120k Every 3 Weeks5.42.60Not reportedNot reportedNot reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks5.32.43Not reportedNot reportedNot reported
BFI Interference
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Epoetin Alfa - 40k Weekly4.31.95Not reportedNot reportedNot reported
Epoetin Alfa - 80k Every 3 Weeks4.12.42Not reportedNot reportedNot reported
Epoetin Alfa - 120k Every 3 Weeks4.32.60Not reportedNot reportedNot reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks4.42.17Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.25
        value
        4.8
      2. group Id
        OG001
        spread
        2.44
        value
        4.6
      3. group Id
        OG002
        spread
        2.53
        value
        4.6
      4. group Id
        OG003
        spread
        2.25
        value
        4.7
    title
    Fatigue Now
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.12
        value
        4.7
      2. group Id
        OG001
        spread
        2.40
        value
        4.7
      3. group Id
        OG002
        spread
        2.53
        value
        4.7
      4. group Id
        OG003
        spread
        2.24
        value
        4.7
    title
    Usual Fatigue
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.17
        value
        5.5
      2. group Id
        OG001
        spread
        2.54
        value
        5.6
      3. group Id
        OG002
        spread
        2.60
        value
        5.4
      4. group Id
        OG003
        spread
        2.43
        value
        5.3
    title
    Worst Fatigue
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.95
        value
        4.3
      2. group Id
        OG001
        spread
        2.42
        value
        4.1
      3. group Id
        OG002
        spread
        2.60
        value
        4.3
      4. group Id
        OG003
        spread
        2.17
        value
        4.4
    title
    BFI Interference
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      58
    4. 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. Brief Fatigue Inventory (BFI) consist of 3 single-item numeric analogue scales on a scale of 0 to 10; and an interference scale formed by 6 single-item numeric scales on a scale of 0 to 10. Higher scores indicate fatigue as bad as you can imagine for fatigue now, usual fatigue and worse fatigue; and completely interferes for BFI interference. Average scores across all time points for fatigue now, usual fatigue, worst fatigue and BFI interference subscale were calculated.
dispersion Type
Standard Deviation
groups
  1. description
    Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
    id
    OG000
    title
    Epoetin Alfa - 40k Weekly
  2. 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
  3. 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
  4. 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 Brief Fatigue Inventory Overall 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