NCT00416624 · OUTCOME

Quality of Life as Measured by Symptom Distress Scale (SDS) Over 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. SDS Scale range: 1 (No Symptom), 5 (Worst Symptom). 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

Nausea Frequency

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	1.6	0.64	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	1.5	0.67	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.6	0.56	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	1.6	0.73	Not reported	Not reported	Not reported

Nausea Severity

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	1.5	0.59	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	1.4	0.62	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.4	0.61	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	1.6	0.73	Not reported	Not reported	Not reported

Appetite

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.3	0.96	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.3	0.94	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.2	0.98	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.4	0.91	Not reported	Not reported	Not reported

Insomnia

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.4	0.99	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.0	0.88	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.3	0.89	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.4	0.91	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	2.7	1.12	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.5	1.15	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.4	1.22	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.7	1.16	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	2.2	0.97	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.0	1.02	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.0	1.05	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.1	0.88	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	3.1	0.82	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	3.0	0.94	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.8	0.97	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.9	0.91	Not reported	Not reported	Not reported

Bowel

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.2	1.00	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.4	1.20	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.3	1.05	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.3	0.95	Not reported	Not reported	Not reported

Concentration

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.2	0.99	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.0	1.00	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.9	0.89	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.2	0.96	Not reported	Not reported	Not reported

Appearance

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.1	0.89	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.2	1.05	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.0	1.09	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.2	0.97	Not reported	Not reported	Not reported

Breathing

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	1.5	0.54	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	1.6	0.64	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.6	0.82	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	1.7	1.01	Not reported	Not reported	Not reported

Outlook

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	2.2	0.98	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	2.1	0.99	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	2.1	0.91	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.4	1.02	Not reported	Not reported	Not reported

Cough

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	1.8	0.77	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	1.7	0.66	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.8	0.69	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.0	0.84	Not reported	Not reported	Not reported

Depression

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Epoetin Alfa - 40k Weekly	1.8	0.64	Not reported	Not reported	Not reported
Epoetin Alfa - 80k Every 3 Weeks	1.7	0.79	Not reported	Not reported	Not reported
Epoetin Alfa - 120k Every 3 Weeks	1.8	0.65	Not reported	Not reported	Not reported
Darbepoetin Alfa - 500 mcg Every 3 Weeks	2.0	0.90	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.64
value
1.6
group Id
OG001
spread
0.67
value
1.5
group Id
OG002
spread
0.56
value
1.6
group Id
OG003
spread
0.73
value
1.6
title
Nausea Frequency
categories
measurements
group Id
OG000
spread
0.59
value
1.5
group Id
OG001
spread
0.62
value
1.4
group Id
OG002
spread
0.61
value
1.4
group Id
OG003
spread
0.73
value
1.6
title
Nausea Severity
categories
measurements
group Id
OG000
spread
0.96
value
2.3
group Id
OG001
spread
0.94
value
2.3
group Id
OG002
spread
0.98
value
2.2
group Id
OG003
spread
0.91
value
2.4
title
Appetite
categories
measurements
group Id
OG000
spread
0.99
value
2.4
group Id
OG001
spread
0.88
value
2.0
group Id
OG002
spread
0.89
value
2.3
group Id
OG003
spread
0.91
value
2.4
title
Insomnia
categories
measurements
group Id
OG000
spread
1.12
value
2.7
group Id
OG001
spread
1.15
value
2.5
group Id
OG002
spread
1.22
value
2.4
group Id
OG003
spread
1.16
value
2.7
title
Pain Frequency
categories
measurements
group Id
OG000
spread
0.97
value
2.2
group Id
OG001
spread
1.02
value
2.0
group Id
OG002
spread
1.05
value
2.0
group Id
OG003
spread
0.88
value
2.1
title
Pain Severity
categories
measurements
group Id
OG000
spread
0.82
value
3.1
group Id
OG001
spread
0.94
value
3.0
group Id
OG002
spread
0.97
value
2.8
group Id
OG003
spread
0.91
value
2.9
title
Fatigue
categories
measurements
group Id
OG000
spread
1.00
value
2.2
group Id
OG001
spread
1.20
value
2.4
group Id
OG002
spread
1.05
value
2.3
group Id
OG003
spread
0.95
value
2.3
title
Bowel
categories
measurements
group Id
OG000
spread
0.99
value
2.2
group Id
OG001
spread
1.00
value
2.0
group Id
OG002
spread
0.89
value
1.9
group Id
OG003
spread
0.96
value
2.2
title
Concentration
categories
measurements
group Id
OG000
spread
0.89
value
2.1
group Id
OG001
spread
1.05
value
2.2
group Id
OG002
spread
1.09
value
2.0
group Id
OG003
spread
0.97
value
2.2
title
Appearance
categories
measurements
group Id
OG000
spread
0.54
value
1.5
group Id
OG001
spread
0.64
value
1.6
group Id
OG002
spread
0.82
value
1.6
group Id
OG003
spread
1.01
value
1.7
title
Breathing
categories
measurements
group Id
OG000
spread
0.98
value
2.2
group Id
OG001
spread
0.99
value
2.1
group Id
OG002
spread
0.91
value
2.1
group Id
OG003
spread
1.02
value
2.4
title
Outlook

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

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 Symptom Distress Scale (SDS) 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