NCT01219673 · ADVERSE EVENTS

Adverse events

Symptom Burden in Head and Neck Cancer · Source last updated 2015-02-10

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: The study was active for 9 months. Participants seen weekly during treatment; continuing toxicity and other clinical variables collected by research staff at weeks 4, 7, 10, through first follow-up visit post radiation treatment.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Placebo by mouth 2 times every day. Placebo: 1 by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported
Armodafinil Armodafinil 150 mg by mouth once a day. Armodafinil: 150 mg by mouth once a day.	0 / 0	0 / 0	Not reported / Not reported
Minocycline Minocycline 100 mg by muth two times a day. Minocycline: 100 mg by mouth twice a day.	0 / 1	0 / 1	Not reported / Not reported
Bupropion Bupropion 100 mg by mouth two times a day. Bupropion: 100 mg by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported
Armodafinil + Minocycline Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported
Armodafinil + Bupropion Armodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Bupropion: 100 mg by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported
Minocycline + Bupropion Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported
Armodafinil + Minocycline + Bupropion Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.	0 / 0	0 / 0	Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Armodafinil · EG002: Minocycline · EG003: Bupropion · EG004: Armodafinil + Minocycline · EG005: Armodafinil + Bupropion · EG006: Minocycline + Bupropion · EG007: Armodafinil + Minocycline + Bupropion

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

description
Placebo by mouth 2 times every day. Placebo: 1 by mouth twice a day.
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Placebo
description
Armodafinil 150 mg by mouth once a day. Armodafinil: 150 mg by mouth once a day.
id
EG001
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Armodafinil
description
Minocycline 100 mg by muth two times a day. Minocycline: 100 mg by mouth twice a day.
id
EG002
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Minocycline
description
Bupropion 100 mg by mouth two times a day. Bupropion: 100 mg by mouth twice a day.
id
EG003
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Bupropion
description
Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day.
id
EG004
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Armodafinil + Minocycline
description
Armodafinil 150 mg by mouth once a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Bupropion: 100 mg by mouth twice a day.
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Armodafinil + Bupropion
description
Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.
id
EG006
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Minocycline + Bupropion
description
Armodafinil 150 mg by mouth once a day. Minocycline 100 mg by muth two times a day. Bupropion 100 mg by mouth two times a day. Armodafinil: 150 mg by mouth once a day. Minocycline: 100 mg by mouth twice a day. Bupropion: 100 mg by mouth twice a day.
id
EG007
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Armodafinil + Minocycline + Bupropion

frequency Threshold

time Frame

The study was active for 9 months. Participants seen weekly during treatment; continuing toxicity and other clinical variables collected by research staff at weeks 4, 7, 10, through first follow-up visit post radiation treatment.

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Preserved source evidence · Not medical advice