NCT01160380 · OUTCOME

Symbol Digit Modalities Test Score (SDMT)

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

What was measured

Test to evaluate neurocognitive functions (attention, visual scanning and motor speed). The test consists of a key =9 graphic symbols numbered 1 to 9 and the test =120 graphic symbols to be matched with its number. The test evaluates the number of correct matches within 90 seconds. 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

Day 1(n=18, 23)

Values in Number of correct matches · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	41.2	9.2	Not reported	Not reported	Not reported
Placebo-First	40.7	14.7	Not reported	Not reported	Not reported

Day 28 (n=19, 23)

Values in Number of correct matches · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	42.4	12.0	Not reported	Not reported	Not reported
Placebo-First	40.8	14.7	Not reported	Not reported	Not reported

Day 56 (n=15)

Values in Number of correct matches · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	48.7	12.3	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
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.699
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
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.984
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
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.239
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.089
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
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.699
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
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.984
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
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.239
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.089
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
9.2
value
41.2
group Id
OG001
spread
14.7
value
40.7
title
Day 1(n=18, 23)
categories
measurements
group Id
OG000
spread
12.0
value
42.4
group Id
OG001
spread
14.7
value
40.8
title
Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
12.3
value
48.7
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

Symbol Digit Modalities Test Score (SDMT)

type

PRIMARY

unit Of Measure

Number of correct matches

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

Preserved source evidence · Not medical advice