NCT00661999 · OUTCOME

Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer · Source last updated 2011-05-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: Scores on a scale
Interval / dispersion: Standard Deviation
Time frame: Baseline and 16 weeks

What was measured

Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.

Groups in this outcome

DA + IV Iron

Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

DA + Oral Iron

Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

DA + Placebo

Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.

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
DA + IV Iron	164
DA + Oral Iron	163
DA + Placebo	163

Reported measurements

Source class 1

Values in Scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
DA + IV Iron	0.4	2.18	Not reported	Not reported	Not reported
DA + Oral Iron	0.2	2.23	Not reported	Not reported	Not reported
DA + Placebo	0.5	2.28	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Pct Value
95
group Description
With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.61
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Pct Value
95
group Description
With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.44
statistical Method
t-test, 2 sided
tested Non Inferiority
false

Complete source fields

analyses

ci Pct Value
95
group Description
With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.61
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Pct Value
95
group Description
With 176 evaluable participants per treatment arm, there would have been \>=80% power to detect a difference across two treatment arms of 33% of the standard deviation in participant QOL through t-test/Wilcoxon test, with a 2.5% type I error rate. A 10 points shift on a 0-100 point scale in QOL measures is generally considered clinically relevant and specifically important in the use of UNISCALE, BFI and FACT-An.
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.44
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
2.18
value
0.4
group Id
OG001
spread
2.23
value
0.2
group Id
OG002
spread
2.28
value
0.5

denoms

counts
group Id
OG000
value
164
group Id
OG001
value
163
group Id
OG002
value
163
units
Participants

description

Overall QOL item score range: 0 (Worst) to 10 (Best), ordinal. Change: score at 16 weeks minus score at baseline.

dispersion Type

Standard Deviation

groups

description
Patients receive darbepoetin alfa (DA) subcutaneously and sodium ferric gluconate complex intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
id
OG000
title
DA + IV Iron
description
Patients receive darbepoetin alfa (DA) as in arm I and oral ferrous sulfate once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
id
OG001
title
DA + Oral Iron
description
Patients receive darbepoetin alfa (DA) as in arm I and oral placebo once daily on days 1-21. Treatment repeats every 21 days for up to 15 weeks in the absence of unacceptable toxicity.
id
OG002
title
DA + Placebo

param Type

MEAN

reporting Status

POSTED

time Frame

Baseline and 16 weeks

title

Change From Baseline in Overall Quality of Life (QOL) Score as Measured by the Linear Analogue Self Assessment (LASA)

type

SECONDARY

unit Of Measure

Scores on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice