NCT01160380 · OUTCOME

Digit Span Test 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: Number of correct items
Interval / dispersion: Standard Deviation
Time frame: Day 1, Day 28 and Day 56

What was measured

Test evaluates working memory and attention. The test consists of repeat numeric sequences of 2 to 9 numbers forward or backwards and evaluates the number of items from a sequence correctly named. Higher scores = better performance.

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

Forward-Day 1 (n=18, 23)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	9.5	2.7	Not reported	Not reported	Not reported
Placebo-First	9.8	2.6	Not reported	Not reported	Not reported

Backward-Day 1 (n=18, 23)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	7.3	2.0	Not reported	Not reported	Not reported
Placebo-First	6.3	2.4	Not reported	Not reported	Not reported

Forward-Day 28 (n=19, 23)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	10.6	3.0	Not reported	Not reported	Not reported
Placebo-First	10.4	2.3	Not reported	Not reported	Not reported

Backward- Day 28 (n=19, 23)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	7.0	2.6	Not reported	Not reported	Not reported
Placebo-First	7.0	2.6	Not reported	Not reported	Not reported

Forward-Day 56 (n=15)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	10.3	2.8	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Backward-Day 56 (n=15)

Values in Number of correct items · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	7.4	2.8	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

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 for the Digit Span Test score-Forward test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.636
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.531
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.037
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.656
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-Digit Span Test score-Forward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.028
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-Digit Span Test score-Backward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.805
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.692
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.863
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 for the Digit Span Test score-Forward test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.636
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment for the Digit Span Test score-Backward test
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.531
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Forward test
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.037
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-Digit Span Test score Backward test
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.656
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-Digit Span Test score-Forward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.028
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-Digit Span Test score-Backward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.805
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Forward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.692
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. day 56 of treatment for the Armodafinil arm-Digit Span Test score-Backward test
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.863
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
2.7
value
9.5
group Id
OG001
spread
2.6
value
9.8
title
Forward-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
2.0
value
7.3
group Id
OG001
spread
2.4
value
6.3
title
Backward-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
3.0
value
10.6
group Id
OG001
spread
2.3
value
10.4
title
Forward-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
2.6
value
7.0
group Id
OG001
spread
2.6
value
7.0
title
Backward- Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
2.8
value
10.3
comment
Day 56 data was only evaluated for the Armodafinil arm
group Id
OG001
spread
NA
value
NA
title
Forward-Day 56 (n=15)
categories
measurements
group Id
OG000
spread
2.8
value
7.4
comment
Day 56 data was only evaluated for the Armodafinil arm
group Id
OG001
spread
NA
value
NA
title
Backward-Day 56 (n=15)

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

Digit Span Test Score

type

PRIMARY

unit Of Measure

Number of correct items

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Preserved source evidence · Not medical advice