NCT00534001 · ADVERSE EVENTS

Adverse events

Bupropion in Helping Adults Stop Smoking · Source last updated 2017-05-30

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: 8 weeks
Other-event reporting threshold: 5%

Only participant-volunteered side effects were noted.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (1-week run-in) Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally	0 / 48	48 / 48	0 / 48
Arm II (4-week run-in) Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally	0 / 47	47 / 47	0 / 47

Group identifiers: EG000: Arm I (1-week run-in) · EG001: Arm II (4-week run-in)

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.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
48
num Events
48
group Id
EG001
num Affected
47
num At Risk
47
num Events
47
term
Any Non-Serious Adverse Event

Complete source fields

description

Only participant-volunteered side effects were noted.

event Groups

deaths Num Affected
0
deaths Num At Risk
48
description
Participants receive an oral placebo once or twice daily in weeks 1-3 followed by oral bupropion hydrochloride once or twice daily in week 4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally placebo: Given orally
id
EG000
other Num Affected
48
other Num At Risk
48
serious Num Affected
0
serious Num At Risk
48
title
Arm I (1-week run-in)
deaths Num Affected
0
deaths Num At Risk
47
description
Participants receive oral bupropion hydrochloride once or twice daily in weeks 1-4. Participants also undergo 90-minute behavioral group counseling sessions once in weeks 1, 2, and 4. bupropion hydrochloride: Given orally
id
EG001
other Num Affected
47
other Num At Risk
47
serious Num Affected
0
serious Num At Risk
47
title
Arm II (4-week run-in)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Adverse events (not including serious) only tracked for clinical monitoring; all participants noted at least one adverse event during the 8-week period of monitoring.
organ System
General disorders
stats
group Id
EG000
num Affected
48
num At Risk
48
num Events
48
group Id
EG001
num Affected
47
num At Risk
47
num Events
47
term
Any Non-Serious Adverse Event

time Frame

8 weeks

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

Preserved source evidence · Not medical advice