NCT00666978 · ADVERSE EVENTS

Adverse events

Health Education Counseling With or Without Bupropion in Helping African Americans Stop Smoking · Source last updated 2017-11-13

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: 16 weeks
Other-event reporting threshold: 3%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Bupropion Arm 270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.	8 / 270	46 / 270	0 / 270
Placebo Arm 270 African American adults received placebo for 7 weeks in addition to health education counseling.	13 / 270	29 / 270	0 / 270

Group identifiers: EG000: Bupropion Arm · EG001: Placebo Arm

Serious adverse events

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

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Chest Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Infection, Skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Muscle Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Upper extremity dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Acoustic nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
2
num At Risk
270
num Events
2
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
2
num At Risk
270
num Events
2
term
Lung infection

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
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
270
num Events
9
group Id
EG001
num Affected
15
num At Risk
270
num Events
15
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
26
num At Risk
270
num Events
26
group Id
EG001
num Affected
9
num At Risk
270
num Events
9
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
270
num Events
11
group Id
EG001
num Affected
5
num At Risk
270
num Events
5
term
Nausea

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
270
description
270 African American adults received bupropion (150mg bid) for 7 weeks in addition to health education counseling.
id
EG000
other Num Affected
46
other Num At Risk
270
serious Num Affected
8
serious Num At Risk
270
title
Bupropion Arm
deaths Num Affected
0
deaths Num At Risk
270
description
270 African American adults received placebo for 7 weeks in addition to health education counseling.
id
EG001
other Num Affected
29
other Num At Risk
270
serious Num Affected
13
serious Num At Risk
270
title
Placebo Arm

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
9
num At Risk
270
num Events
9
group Id
EG001
num Affected
15
num At Risk
270
num Events
15
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
26
num At Risk
270
num Events
26
group Id
EG001
num Affected
9
num At Risk
270
num Events
9
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
11
num At Risk
270
num Events
11
group Id
EG001
num Affected
5
num At Risk
270
num Events
5
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Atrioventricular block
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Chest Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Infection, Skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Muscle Weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Syncope
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
270
num Events
1
group Id
EG001
num Affected
0
num At Risk
270
num Events
0
term
Upper extremity dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Acoustic nerve disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
1
num At Risk
270
num Events
1
term
Coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
2
num At Risk
270
num Events
2
term
Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
0
num At Risk
270
num Events
0
group Id
EG001
num Affected
2
num At Risk
270
num Events
2
term
Lung infection

time Frame

16 weeks

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Preserved source evidence · Not medical advice