NCT01032200 · OUTCOME

Adherence

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors · Source last updated 2021-09-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: percentage of ideal number of pills
Interval / dispersion: Full Range
Time frame: 4 weeks post-RT (approximately 3 months post randomization)

What was measured

Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)

Analysis population: Participants who returned pill diaries

Groups in this outcome

Arm I - Armodafinil

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally

Arm II - Placebo

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally

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
Arm I - Armodafinil	22
Arm II - Placebo	25

Reported measurements

Source class 1

Values in percentage of ideal number of pills · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Arm I - Armodafinil	92.6	Not reported	0	100	Not reported
Arm II - Placebo	95.7	Not reported	70.3	100	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0
upper Limit
100
value
92.6
group Id
OG001
lower Limit
70.3
upper Limit
100
value
95.7

denoms

counts
group Id
OG000
value
22
group Id
OG001
value
25
units
Participants

description

Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)

dispersion Type

Full Range

groups

description
Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally
id
OG000
title
Arm I - Armodafinil
description
Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally
id
OG001
title
Arm II - Placebo

param Type

MEAN

population Description

Participants who returned pill diaries

reporting Status

POSTED

time Frame

4 weeks post-RT (approximately 3 months post randomization)

title

Adherence

type

PRIMARY

unit Of Measure

percentage of ideal number of pills

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

Preserved source evidence · Not medical advice