NCT01160380 · OUTCOME

Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) 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 addressing fatigue and patient happiness, coping, etc. Used to assess quality of life. The test consists of 40 items, each item with a response scale of 0-4. Higher scores denote better status Items are added to provide the total score (range 0-160).

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

PWB-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	14.1	3.3	Not reported	Not reported	Not reported
Placebo-First	15.3	5.1	Not reported	Not reported	Not reported

SWB-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	20.9	6.7	Not reported	Not reported	Not reported
Placebo-First	19.8	5.1	Not reported	Not reported	Not reported

EWB-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	16.9	4.3	Not reported	Not reported	Not reported
Placebo-First	17.5	3.7	Not reported	Not reported	Not reported

FWB-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	14.8	3.6	Not reported	Not reported	Not reported
Placebo-First	14.6	4.2	Not reported	Not reported	Not reported

Fatigue-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	19.2	8.7	Not reported	Not reported	Not reported
Placebo-First	18.8	8.9	Not reported	Not reported	Not reported

FACIT-G-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	67.0	11.6	Not reported	Not reported	Not reported
Placebo-First	68.9	11.4	Not reported	Not reported	Not reported

TOI-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	49.0	12.2	Not reported	Not reported	Not reported
Placebo-First	49.4	15.3	Not reported	Not reported	Not reported

Total-Day 1 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	86.2	15.8	Not reported	Not reported	Not reported
Placebo-First	86.1	20.4	Not reported	Not reported	Not reported

PWB-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	16.5	6.6	Not reported	Not reported	Not reported
Placebo-First	17.4	6.3	Not reported	Not reported	Not reported

EWB-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	16.5	5.3	Not reported	Not reported	Not reported
Placebo-First	18.7	4.3	Not reported	Not reported	Not reported

SWB-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	21.3	7.5	Not reported	Not reported	Not reported
Placebo-First	20.8	5.4	Not reported	Not reported	Not reported

FWB-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	14.4	5.1	Not reported	Not reported	Not reported
Placebo-First	16.8	4.5	Not reported	Not reported	Not reported

Fatigue-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	28.0	13.22	Not reported	Not reported	Not reported
Placebo-First	26.5	11.7	Not reported	Not reported	Not reported

FACIT-G-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	68.5	20.5	Not reported	Not reported	Not reported
Placebo-First	75.8	12.9	Not reported	Not reported	Not reported

TOI-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	59.4	23.5	Not reported	Not reported	Not reported
Placebo-First	62.9	18.7	Not reported	Not reported	Not reported

Total-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	96.5	31.3	Not reported	Not reported	Not reported
Placebo-First	101.3	21.9	Not reported	Not reported	Not reported

PWB-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	17.8	5.1	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

EWB-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	22.1	5.7	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

SWB-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	18.7	3.4	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

FWB-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	13.5	3.8	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Fatigue-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	29.7	9.2	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

FACIT-G-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	73.2	12.1	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

TOI-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	62.7	14.6	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Total-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	101.8	18.7	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 for Day 28 of treatment- FACIT-F total
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.559
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.192
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.495
statistical Method
t-test, 2 sided
tested Non Inferiority
false

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Comparison between arms for Day 28 of treatment- FACIT-F total
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.559
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm- FACIT-F total
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.001
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Armodafinil arm- FACIT-F total
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.192
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56of treatment for the Armodafinil arm- FACIT-F total
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.495
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
3.3
value
14.1
group Id
OG001
spread
5.1
value
15.3
title
PWB-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
6.7
value
20.9
group Id
OG001
spread
5.1
value
19.8
title
SWB-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
4.3
value
16.9
group Id
OG001
spread
3.7
value
17.5
title
EWB-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
3.6
value
14.8
group Id
OG001
spread
4.2
value
14.6
title
FWB-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
8.7
value
19.2
group Id
OG001
spread
8.9
value
18.8
title
Fatigue-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
11.6
value
67.0
group Id
OG001
spread
11.4
value
68.9
title
FACIT-G-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
12.2
value
49.0
group Id
OG001
spread
15.3
value
49.4
title
TOI-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
15.8
value
86.2
group Id
OG001
spread
20.4
value
86.1
title
Total-Day 1 (n=19, 23)
categories
measurements
group Id
OG000
spread
6.6
value
16.5
group Id
OG001
spread
6.3
value
17.4
title
PWB-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
5.3
value
16.5
group Id
OG001
spread
4.3
value
18.7
title
EWB-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
7.5
value
21.3
group Id
OG001
spread
5.4
value
20.8
title
SWB-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
5.1
value
14.4
group Id
OG001
spread
4.5
value
16.8
title
FWB-Day 28 (n=19, 23)

denoms

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

description

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

Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) Score

type

SECONDARY

unit Of Measure

units on a scale

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

Preserved source evidence · Not medical advice