NCT01032200 · OUTCOME

Retention

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: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: 4 weeks post-RT (approximately 3 months post randomization)

What was measured

Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.

Analysis population: All randomized participants

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	26
Arm II - Placebo	28

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I - Armodafinil	85	Not reported	Not reported	Not reported	Not reported
Arm II - Placebo	75	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
85
group Id
OG001
value
75

denoms

counts
group Id
OG000
value
26
group Id
OG001
value
28
units
Participants

description

Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.

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

NUMBER

population Description

All randomized participants

reporting Status

POSTED

time Frame

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

title

Retention

type

PRIMARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice