Trial Outcomes & Findings for Pharmacogenetics of Nicotine Addiction Treatment (NCT NCT01314001)
NCT ID: NCT01314001
Last Updated: 2016-03-03
Results Overview
The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1246 participants
Primary outcome timeframe
Week 11
Results posted on
2016-03-03
Participant Flow
The trial was conducted at four academic medical centers. From 11/16/2010 to 9/16/2013, participants were recruited through advertisements for a free smoking cessation program.
Subjects were randomly assigned to one of three treatment groups in a 1:1:1 ratio: "Placebo"; "Nicotine Patch"; or "Varenicline". Randomization was stratified by nicotine metabolite ratio - slow metabolizers of nicotine vs. normal metabolizers - and study site and blocked in blocks of 12 to maintain balance. Slow metabolizers were over-sampled.
Participant milestones
| Measure |
Placebo (Slow Metabolizers)
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
215
|
193
|
227
|
191
|
220
|
200
|
|
Overall Study
End-of-Treatment Visit
|
156
|
141
|
179
|
146
|
174
|
160
|
|
Overall Study
6-Month Follow Up Survey
|
146
|
137
|
165
|
135
|
157
|
139
|
|
Overall Study
COMPLETED
|
140
|
124
|
158
|
122
|
148
|
129
|
|
Overall Study
NOT COMPLETED
|
75
|
69
|
69
|
69
|
72
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenetics of Nicotine Addiction Treatment
Baseline characteristics by cohort
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Total
n=1246 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 11 • n=99 Participants
|
47 years
STANDARD_DEVIATION 11 • n=107 Participants
|
46 years
STANDARD_DEVIATION 11 • n=206 Participants
|
46 years
STANDARD_DEVIATION 11 • n=7 Participants
|
44 years
STANDARD_DEVIATION 12 • n=31 Participants
|
46 years
STANDARD_DEVIATION 12 • n=30 Participants
|
45 years
STANDARD_DEVIATION 11 • n=3 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
94 Participants
n=7 Participants
|
88 Participants
n=31 Participants
|
99 Participants
n=30 Participants
|
543 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
97 Participants
n=7 Participants
|
132 Participants
n=31 Participants
|
101 Participants
n=30 Participants
|
703 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
97 participants
n=99 Participants
|
128 participants
n=107 Participants
|
117 participants
n=206 Participants
|
119 participants
n=7 Participants
|
99 participants
n=31 Participants
|
133 participants
n=30 Participants
|
693 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Black
|
95 participants
n=99 Participants
|
56 participants
n=107 Participants
|
94 participants
n=206 Participants
|
57 participants
n=7 Participants
|
107 participants
n=31 Participants
|
53 participants
n=30 Participants
|
462 participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
23 participants
n=99 Participants
|
9 participants
n=107 Participants
|
16 participants
n=206 Participants
|
15 participants
n=7 Participants
|
14 participants
n=31 Participants
|
14 participants
n=30 Participants
|
91 participants
n=3 Participants
|
|
Region of Enrollment
Canada
|
47 participants
n=99 Participants
|
43 participants
n=107 Participants
|
52 participants
n=206 Participants
|
42 participants
n=7 Participants
|
48 participants
n=31 Participants
|
44 participants
n=30 Participants
|
276 participants
n=3 Participants
|
|
Region of Enrollment
United States
|
168 participants
n=99 Participants
|
150 participants
n=107 Participants
|
175 participants
n=206 Participants
|
149 participants
n=7 Participants
|
172 participants
n=31 Participants
|
156 participants
n=30 Participants
|
970 participants
n=3 Participants
|
|
Education level
High school education or lower
|
68 participants
n=99 Participants
|
57 participants
n=107 Participants
|
78 participants
n=206 Participants
|
49 participants
n=7 Participants
|
74 participants
n=31 Participants
|
61 participants
n=30 Participants
|
387 participants
n=3 Participants
|
|
Education level
Post-high school education
|
147 participants
n=99 Participants
|
136 participants
n=107 Participants
|
149 participants
n=206 Participants
|
142 participants
n=7 Participants
|
146 participants
n=31 Participants
|
139 participants
n=30 Participants
|
859 participants
n=3 Participants
|
|
Annual Income (US dollars)
Greater than or equal to US$50,000
|
65 participants
n=99 Participants
|
79 participants
n=107 Participants
|
82 participants
n=206 Participants
|
75 participants
n=7 Participants
|
74 participants
n=31 Participants
|
71 participants
n=30 Participants
|
446 participants
n=3 Participants
|
|
Annual Income (US dollars)
Less than US$50,000
|
150 participants
n=99 Participants
|
114 participants
n=107 Participants
|
145 participants
n=206 Participants
|
116 participants
n=7 Participants
|
146 participants
n=31 Participants
|
129 participants
n=30 Participants
|
800 participants
n=3 Participants
|
|
Employment Status
Not employed
|
79 participants
n=99 Participants
|
84 participants
n=107 Participants
|
69 participants
n=206 Participants
|
71 participants
n=7 Participants
|
88 participants
n=31 Participants
|
75 participants
n=30 Participants
|
466 participants
n=3 Participants
|
|
Employment Status
Employed
|
136 participants
n=99 Participants
|
109 participants
n=107 Participants
|
158 participants
n=206 Participants
|
120 participants
n=7 Participants
|
132 participants
n=31 Participants
|
125 participants
n=30 Participants
|
780 participants
n=3 Participants
|
|
FTND Score
|
5.3 units on a scale
STANDARD_DEVIATION 1.92 • n=99 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.00 • n=107 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 2.00 • n=206 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 1.89 • n=7 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 2.00 • n=31 Participants
|
2.1 units on a scale
STANDARD_DEVIATION 2.02 • n=30 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.97 • n=3 Participants
|
|
Cigarettes per day
|
17.6 cigarettes per day
STANDARD_DEVIATION 7.0 • n=99 Participants
|
19.6 cigarettes per day
STANDARD_DEVIATION 8.7 • n=107 Participants
|
17.6 cigarettes per day
STANDARD_DEVIATION 7.0 • n=206 Participants
|
18.5 cigarettes per day
STANDARD_DEVIATION 7.0 • n=7 Participants
|
16.7 cigarettes per day
STANDARD_DEVIATION 5.4 • n=31 Participants
|
18.4 cigarettes per day
STANDARD_DEVIATION 6.3 • n=30 Participants
|
18.0 cigarettes per day
STANDARD_DEVIATION 7.0 • n=3 Participants
|
PRIMARY outcome
Timeframe: Week 11Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The percentage of ITT subjects who were verified as abstinent. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
7-day Point Prevalence Quit Rate at End-of-Treatment (EOT)
|
17.2 percentage of ITT subjects
|
18.6 percentage of ITT subjects
|
27.7 percentage of ITT subjects
|
22.5 percentage of ITT subjects
|
30.4 percentage of ITT subjects
|
38.5 percentage of ITT subjects
|
SECONDARY outcome
Timeframe: Week 24Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The percentage of ITT subjects who were verified as abstinent at the 6-month follow up survey. Abstinence was defined as no self-reported smoking (not even a puff) for at least 7 days before the telephone assessment, with in-person verification for those self-reporting abstinence. In-person verification consisted of breath carbon monoxide analysis, with a reading of 8 parts-per-million or less confirming abstinence. Subjects who were lost to follow-up were considered smokers.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
7-day Point Prevalence Quit Rate at 6-month Follow up Survey
|
14.4 percentage of ITT subjects
|
12.9 percentage of ITT subjects
|
21.6 percentage of ITT subjects
|
13.6 percentage of ITT subjects
|
19.1 percentage of ITT subjects
|
22.0 percentage of ITT subjects
|
SECONDARY outcome
Timeframe: Pre-Quit (Week -1/Baseline)Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Total Side-Effect Severity Index at Pre-Quit
|
3.95 units on a scale
Standard Deviation 4.84
|
3.40 units on a scale
Standard Deviation 4.34
|
3.26 units on a scale
Standard Deviation 3.97
|
3.97 units on a scale
Standard Deviation 4.74
|
3.05 units on a scale
Standard Deviation 3.93
|
3.57 units on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Target Quit Date (Week 0)Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Total Side-Effect Severity Index at Target Quit Date
|
4.22 units on a scale
Standard Deviation 4.37
|
4.27 units on a scale
Standard Deviation 4.57
|
3.98 units on a scale
Standard Deviation 3.59
|
4.28 units on a scale
Standard Deviation 4.96
|
4.68 units on a scale
Standard Deviation 4.66
|
4.06 units on a scale
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Week 1Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Total Side-Effect Severity Index at Week 1
|
5.58 units on a scale
Standard Deviation 5.08
|
5.46 units on a scale
Standard Deviation 5.00
|
5.44 units on a scale
Standard Deviation 5.03
|
5.58 units on a scale
Standard Deviation 5.48
|
6.04 units on a scale
Standard Deviation 5.23
|
5.26 units on a scale
Standard Deviation 4.98
|
SECONDARY outcome
Timeframe: Week 4Population: Intent-to-treat population (all subjects who received at least one dose of intervention).
The mean side-effect severity score by treatment group (placebo vs. nicotine patch vs. varenicline) and by NMR group (slow metabolizers vs. normal metabolizers). Side-effect severity was calculated using a Side Effects Checklists (SEC). 29 common side-effects associated with transdermal nicotine or varenicline treatment were rated by participants on a 0 (none) to 3 (severe) scale. For each participant at this timepoint, these scores were summed to calculate a total score, with a range of 0 to 87; a higher score indicated a higher severity of side-effects.
Outcome measures
| Measure |
Placebo (Slow Metabolizers)
n=215 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 Participants
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 Participants
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 Participants
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 Participants
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Total Side-Effect Severity Index at Week 4
|
5.33 units on a scale
Standard Deviation 5.70
|
4.93 units on a scale
Standard Deviation 5.68
|
4.24 units on a scale
Standard Deviation 4.40
|
4.52 units on a scale
Standard Deviation 5.46
|
4.97 units on a scale
Standard Deviation 4.88
|
4.39 units on a scale
Standard Deviation 3.96
|
Adverse Events
Placebo (Slow Metabolizers)
Serious events: 10 serious events
Other events: 194 other events
Deaths: 0 deaths
Placebo (Normal Metabolizers)
Serious events: 6 serious events
Other events: 171 other events
Deaths: 0 deaths
Nicotine Patch (Slow Metabolizers)
Serious events: 11 serious events
Other events: 206 other events
Deaths: 0 deaths
Nicotine Patch (Normal Metabolizers)
Serious events: 11 serious events
Other events: 169 other events
Deaths: 0 deaths
Varenicline (Slow Metabolizers)
Serious events: 3 serious events
Other events: 210 other events
Deaths: 0 deaths
Varenicline (Normal Metabolizers)
Serious events: 8 serious events
Other events: 185 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Slow Metabolizers)
n=215 participants at risk
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 participants at risk
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 participants at risk
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 participants at risk
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 participants at risk
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 participants at risk
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Cardiac disorders
Heart Attack
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Endocrine disorders
Diabetes diagnosis
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.45%
1/220 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Severe nausea/vomiting/abdominal pain
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Tongue Swelling
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Death
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Hepatobiliary disorders
Gall bladder issues
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.45%
1/220 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Ankle injury
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Broken bones
|
0.93%
2/215 • Number of events 2 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Knee injuries
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.45%
1/220 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer; colon
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer; lung
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer; oral
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer; throat
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Moderate cervical dysplasia
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Nervous system disorders
Seizures; cause unknown
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Mood changes
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Panic Attacks
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Sleep problems
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Suicidal thoughts
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
1.0%
2/200 • Number of events 2 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Renal and urinary disorders
Kidney stone procedure
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
COPD diagnosis
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Respiratory, thoracic and mediastinal disorders
Severe asthma attack
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Surgical and medical procedures
Abscess drainage; surgery
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Surgical and medical procedures
Skin/bone biopsy
|
0.00%
0/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/191 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Vascular disorders
Brain aneurysm
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Vascular disorders
Pulmonary embolism
|
0.47%
1/215 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Vascular disorders
Stroke
|
0.93%
2/215 • Number of events 2 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Number of events 1 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
Other adverse events
| Measure |
Placebo (Slow Metabolizers)
n=215 participants at risk
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Placebo (Normal Metabolizers)
n=193 participants at risk
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing placebo patches daily for 11 weeks
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Slow Metabolizers)
n=227 participants at risk
Slow metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Nicotine Patch (Normal Metabolizers)
n=191 participants at risk
Normal metabolizers
* Taking placebo pills daily for 12 weeks
* Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)
* Received smoking cessation counseling during their sessions
|
Varenicline (Slow Metabolizers)
n=220 participants at risk
Slow metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
Varenicline (Normal Metabolizers)
n=200 participants at risk
Normal metabolizers
* Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)
* Wearing placebo patches for 11 weeks
* Received smoking cessation counseling during their sessions
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Chest Pain
|
6.5%
14/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
6.2%
12/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
4.8%
11/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
3.7%
7/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
5.9%
13/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
3.5%
7/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Cardiac disorders
Heart Palpitations
|
13.0%
28/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
11.4%
22/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
8.8%
20/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
7.9%
15/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
9.1%
20/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
7.5%
15/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Cardiac disorders
Irregular Heartbeat
|
4.7%
10/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
4.7%
9/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
2.6%
6/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
2.6%
5/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
2.7%
6/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
2.0%
4/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.2%
22/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
9.8%
19/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
13.7%
31/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
11.5%
22/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
19.5%
43/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
14.5%
29/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
67/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
22.8%
44/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
22.0%
50/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
26.2%
50/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
32.3%
71/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
24.0%
48/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Diarrhea
|
14.9%
32/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
23.3%
45/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
13.2%
30/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
12.6%
24/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
17.3%
38/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
12.0%
24/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Flatulence
|
38.1%
82/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
39.9%
77/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
37.4%
85/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
36.1%
69/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
42.7%
94/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
40.5%
81/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Gas
|
51.2%
110/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
52.3%
101/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
47.6%
108/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
47.6%
91/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
50.5%
111/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
49.0%
98/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Indigestion
|
23.3%
50/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
21.8%
42/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
19.8%
45/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
18.8%
36/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
22.7%
50/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
27.0%
54/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Nausea
|
28.4%
61/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
25.9%
50/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
21.1%
48/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
20.9%
40/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
44.1%
97/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
47.0%
94/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
11/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
2.6%
5/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
1.8%
4/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
3.1%
6/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
5.9%
13/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
6.0%
12/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Dizziness
|
13.0%
28/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
14.5%
28/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
11.5%
26/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
8.4%
16/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
17.7%
39/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
9.5%
19/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Dry Mouth
|
41.4%
89/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
36.8%
71/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
43.6%
99/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
38.7%
74/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
50.5%
111/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
31.0%
62/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Fatigue
|
34.0%
73/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
36.8%
71/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
38.8%
88/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
34.0%
65/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
40.0%
88/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
39.5%
79/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
General disorders
Headache
|
44.2%
95/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
38.3%
74/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
33.0%
75/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
33.5%
64/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
40.0%
88/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
30.0%
60/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Body Weakness
|
4.2%
9/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
4.7%
9/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
3.1%
7/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
4.2%
8/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
9.1%
20/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
3.0%
6/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Musculoskeletal and connective tissue disorders
Feel Weakness
|
16.7%
36/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
19.2%
37/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
18.1%
41/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
16.8%
32/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
20.5%
45/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
15.0%
30/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Abnormal Dreams
|
31.6%
68/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
33.2%
64/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
41.4%
94/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
46.1%
88/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
44.1%
97/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
44.5%
89/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Agitation
|
47.9%
103/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
49.2%
95/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
46.3%
105/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
50.3%
96/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
40.9%
90/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
42.0%
84/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Anxiety
|
34.4%
74/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
45.1%
87/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
37.0%
84/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
45.0%
86/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
32.3%
71/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
36.5%
73/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Depressed Mood
|
23.7%
51/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
26.9%
52/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
29.1%
66/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
27.2%
52/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
25.5%
56/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
24.5%
49/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Disturbed Attention
|
25.1%
54/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
25.9%
50/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
20.3%
46/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
24.6%
47/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
24.1%
53/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
20.0%
40/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Hostility
|
25.1%
54/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
22.8%
44/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
17.2%
39/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
22.5%
43/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
19.1%
42/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
21.5%
43/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Insomnia
|
32.6%
70/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
32.6%
63/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
31.7%
72/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
33.5%
64/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
37.7%
83/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
30.0%
60/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Irritability
|
58.1%
125/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
63.7%
123/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
57.3%
130/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
62.3%
119/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
58.2%
128/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
57.0%
114/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Sleep Problems
|
50.7%
109/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
42.0%
81/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
45.4%
103/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
52.4%
100/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
53.6%
118/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
54.5%
109/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Psychiatric disorders
Suicidal Thoughts
|
1.9%
4/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.52%
1/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.44%
1/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.00%
0/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.45%
1/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
0.50%
1/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Skin Redness
|
7.9%
17/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
7.8%
15/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
18.5%
42/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
13.6%
26/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
10.5%
23/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
8.5%
17/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
|
Skin and subcutaneous tissue disorders
Skin Swelling/Rash
|
10.7%
23/215 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
10.9%
21/193 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
11.0%
25/227 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
12.0%
23/191 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
13.6%
30/220 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
7.0%
14/200 • Adverse event data were collected throughout the entire span of each subject's participation, which is approximately 1 year, 1 month (from initial phone screening to the 12-month follow up survey).
Systematic Assessment: subjects completed a side effect checklist (SEC) during each study session over the course of the treatment period (target quit date through end-of-treatment). The SEC listed anticipated side effects that could be caused by the study medication. Subjects could also spontaneously report AEs at any time.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place