NCT00790569 · ADVERSE EVENTS

Adverse events

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking · Source last updated 2018-06-06

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally	4 / 137	0 / 137	Not reported / Not reported
Arm II Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally	2 / 45	0 / 45	Not reported / Not reported
Arm III Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally	2 / 133	0 / 133	Not reported / Not reported

Group identifiers: EG000: Arm I · EG001: Arm II · EG002: Arm III

Serious adverse events

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

notes
Participant described hearing voices
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Neurobehavioral Adverse Effects
notes
Participant reported mood disturbance
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Neurobehavioral Adverse Events
notes
Participant died during study participation
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
137
num Events
0
group Id
EG001
num Affected
2
num At Risk
45
num Events
2
group Id
EG002
num Affected
1
num At Risk
133
num Events
1
term
Participant Death
notes
Participant was hospitalized with symptoms of heat attack
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
137
num Events
0
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
1
num At Risk
133
num Events
1
term
Heart Attack
notes
Participants complained of skin rashes
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
137
num Events
2
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Skin Rash

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
Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. varenicline: Given orally
id
EG000
other Num Affected
0
other Num At Risk
137
serious Num Affected
4
serious Num At Risk
137
title
Arm I
description
Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached. placebo: Given orally
id
EG001
other Num Affected
0
other Num At Risk
45
serious Num Affected
2
serious Num At Risk
45
title
Arm II
description
Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached. nicotine: Given transdermally and orally
id
EG002
other Num Affected
0
other Num At Risk
133
serious Num Affected
2
serious Num At Risk
133
title
Arm III

frequency Threshold

serious Events

notes
Participant described hearing voices
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Neurobehavioral Adverse Effects
notes
Participant reported mood disturbance
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Neurobehavioral Adverse Events
notes
Participant died during study participation
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
137
num Events
0
group Id
EG001
num Affected
2
num At Risk
45
num Events
2
group Id
EG002
num Affected
1
num At Risk
133
num Events
1
term
Participant Death
notes
Participant was hospitalized with symptoms of heat attack
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
0
num At Risk
137
num Events
0
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
1
num At Risk
133
num Events
1
term
Heart Attack
notes
Participants complained of skin rashes
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
2
num At Risk
137
num Events
2
group Id
EG001
num Affected
0
num At Risk
45
num Events
0
group Id
EG002
num Affected
0
num At Risk
133
num Events
0
term
Skin Rash

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Preserved source evidence · Not medical advice