NCT01160380 · OUTCOME

Trail Making Test B Score (TMT-B)

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: seconds
Interval / dispersion: Standard Deviation
Time frame: Day 1, Day 28 and Day 56

What was measured

Cognitive test that gives a measure of various aspects of cognitive performance. Used to measure cognitive fatigue. The test consists of 25 circles containing 13 sequential numbers (1-13) and 12 sequential letters (A-L) positioned. The test evaluates the time to correctly order letters and numbers; low times = 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

Day 1(n=18, 23)

Values in seconds · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	161.3	77.8	Not reported	Not reported	Not reported
Placebo-First	220.5	163.2	Not reported	Not reported	Not reported

Day 28 (n=19, 23)

Values in seconds · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	158.4	81.2	Not reported	Not reported	Not reported
Placebo-First	159.8	94.2	Not reported	Not reported	Not reported

Day 56 (n=15)

Values in seconds · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	153.8	78.7	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 at Day 28 of treatment
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.954
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
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.007
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 Armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.369
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
0.973
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
0.954
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
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.007
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 Armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.369
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
0.973
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
77.8
value
161.3
group Id
OG001
spread
163.2
value
220.5
title
Day 1(n=18, 23)
categories
measurements
group Id
OG000
spread
81.2
value
158.4
group Id
OG001
spread
94.2
value
159.8
title
Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
78.7
value
153.8
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

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

Trail Making Test B Score (TMT-B)

type

PRIMARY

unit Of Measure

seconds

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

Preserved source evidence · Not medical advice