NCT01160380 · OUTCOME

BFI Score

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma · Source last updated 2014-11-06

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: Day 1, Day 28 and Day 56

What was measured

Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

Groups in this outcome

Armodafinil

The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily.

Placebo-First

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

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
Armodafinil	25
Placebo-First	25

Reported measurements

Day 1(n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	65.0	13.2	Not reported	Not reported	Not reported
Placebo-First	57.2	14.3	Not reported	Not reported	Not reported

Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	48.8	22.4	Not reported	Not reported	Not reported
Placebo-First	41.5	18.4	Not reported	Not reported	Not reported

Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	43.2	18.9	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Source statistical analyses

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

ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.289
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 1 and Day 28
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 1 and day 28
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.002
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 28 and Day 56 of treatment for the armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.449
statistical Method
t-test, 2 sided
tested Non Inferiority
false

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.289
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 1 and Day 28
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 1 and day 28
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.002
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between Day 28 and Day 56 of treatment for the armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.449
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
13.2
value
65.0
group Id
OG001
spread
14.3
value
57.2
title
Day 1(n=18, 23)
categories
measurements
group Id
OG000
spread
22.4
value
48.8
group Id
OG001
spread
18.4
value
41.5
title
Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
18.9
value
43.2
comment
Day 56 data was only evaluated for the Armodafinil arm
group Id
OG001
spread
NA
value
NA
title
Day 56 (n=15)

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
25
units
Participants

description

Survey measuring fatigue. The scale contains 9 items; range=0-90 (0-10 per item). Mild = 1-3 Moderate = 4-7 Severe = 8-10

dispersion Type

Standard Deviation

groups

description
The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily.
id
OG000
title
Armodafinil
description
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
id
OG001
title
Placebo-First

param Type

MEAN

reporting Status

POSTED

time Frame

Day 1, Day 28 and Day 56

title

BFI Score

type

PRIMARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice