Trial Outcomes & Findings for Genetically Informed Smoking Cessation Trial (NCT NCT02351167)
NCT ID: NCT02351167
Last Updated: 2020-09-22
Results Overview
The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
822 participants
Primary outcome timeframe
Week 12
Results posted on
2020-09-22
Participant Flow
The study opened to participant enrollment on 05/20/2015 and closed to participant enrollment on 07/23/2018.
-The study consented 894 participants and 72 were excluded after consenting due to no longer wanting to participate or not meeting all the eligibility criteria prior to randomization. The 72 were not considered enrolled in the study per the policy of the institution.
Participant milestones
| Measure |
Combination NRT and Counseling
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
275
|
274
|
273
|
|
Overall Study
COMPLETED
|
256
|
256
|
252
|
|
Overall Study
NOT COMPLETED
|
19
|
18
|
21
|
Reasons for withdrawal
| Measure |
Combination NRT and Counseling
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
19
|
18
|
21
|
Baseline Characteristics
Genetically Informed Smoking Cessation Trial
Baseline characteristics by cohort
| Measure |
Combination NRT and Counseling
n=275 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Total
n=822 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
261 Participants
n=99 Participants
|
262 Participants
n=107 Participants
|
258 Participants
n=206 Participants
|
781 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=157 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
46.6 years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
46.6 years
STANDARD_DEVIATION 11.5 • n=206 Participants
|
46.5 years
STANDARD_DEVIATION 11.2 • n=157 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
449 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
373 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
271 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
804 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
97 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
270 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
168 Participants
n=99 Participants
|
169 Participants
n=107 Participants
|
179 Participants
n=206 Participants
|
516 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
275 participants
n=99 Participants
|
274 participants
n=107 Participants
|
273 participants
n=206 Participants
|
822 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Week 12The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Outcome measures
| Measure |
Combination NRT and Counseling
n=275 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
7-day Point Prevalence Quit Rate
|
55 Participants
|
70 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 weeks (with first 1 week initial grace period)The definition of this measure requires: Not taking even 1 cigarette puff from target quit date to end of treatment.
Outcome measures
| Measure |
Combination NRT and Counseling
n=275 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Continuous Abstinence
|
43 Participants
|
46 Participants
|
21 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24The definition of this measure requires: (a) no self-reported smoking (not even a puff of a cigarette) for at least the 7 days prior to the assessment, and (b) biochemical verification of abstinence.
Outcome measures
| Measure |
Combination NRT and Counseling
n=275 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
7-day Point Prevalence Quit Rate
|
37 Participants
|
56 Participants
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Assessed from the target quit day through 52 weeksPopulation: 26 participants in Combination NRT \& Counseling, 19 participants in Varenicline (Chantix) \& Counseling, \& 16 participants in Placebo Medicine \& Counseling did not lapse by the end of the 52 weeks. 4 participants in Combination NRT \& Counseling, 9 participants in Varenicline (Chantix) \& Counseling, \& 5 participants had missing information on lapse.
* The number of days to lapse is defined as the number of days from the target quit date until the participant reports smoking (even a single puff). * Participants who did not lapse by the end of the 52 weeks and participants who had missing information on lapse are not included in the overall number of participants analyzed
Outcome measures
| Measure |
Combination NRT and Counseling
n=245 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=246 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=252 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
n=743 Participants
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Number of Days to Lapse
|
16.78 days
Standard Error 2.48
|
20.47 days
Standard Error 3.22
|
11.85 days
Standard Error 2.07
|
16.33 days
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Assessed from the target quit day through 52 weeksPopulation: 76 participants in Combination NRT \& Counseling, 66 participants in Varenicline (Chantix) \& Counseling, \& 51 participants in Placebo Medicine \& Counseling did not relapse by the end of 52 weeks. 4 participants in Combination NRT \& Counseling, 9 participants in Varenicline (Chantix) \& Counseling, \& 5 participants had missing information on relapse
* The number of days to relapse is defined as the number of days from the target quit day until the first of seven consecutive days of smoking. * Participants who did not relapse by the end of the 52 weeks and participants who had missing information on relapse are not included in the overall number of participants analyzed
Outcome measures
| Measure |
Combination NRT and Counseling
n=195 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=199 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=217 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
n=611 Participants
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Number of Days to Relapse
|
44.83 days
Standard Error 4.25
|
45.01 days
Standard Error 5.04
|
28.87 days
Standard Error 3.75
|
39.22 days
Standard Error 2.53
|
SECONDARY outcome
Timeframe: Assessed for the first seven days after the target quit dateDefined as at least 1 day of abstinence during the first 7 days after the target quit day.
Outcome measures
| Measure |
Combination NRT and Counseling
n=275 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Initial Cessation
|
217 Participants
|
186 Participants
|
172 Participants
|
—
|
SECONDARY outcome
Timeframe: 0-52 WeeksPopulation: Participants who had missing data are not included in the number of participants analyzed
-The definition of this measure requires; no self-reported smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment.
Outcome measures
| Measure |
Combination NRT and Counseling
n=271 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=268 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=270 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
n=809 Participants
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
0 weeks - Abstinence
|
5 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
1 week - Abstinence
|
91 Participants
|
94 Participants
|
70 Participants
|
255 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
2 week - Abstinence
|
119 Participants
|
105 Participants
|
70 Participants
|
294 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
4 week - Abstinence
|
112 Participants
|
114 Participants
|
74 Participants
|
300 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
12 week - Abstinence
|
81 Participants
|
88 Participants
|
49 Participants
|
218 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
26 week - Abstinence
|
75 Participants
|
82 Participants
|
49 Participants
|
206 Participants
|
|
Longitudinal Models of Abstinence Outcomes Across Multiple Time Points
52 week - Abstinence
|
68 Participants
|
77 Participants
|
43 Participants
|
188 Participants
|
SECONDARY outcome
Timeframe: 0-52 WeeksPopulation: Participants who had missing data are not included in the number of participants analyzed
The definition of this measure requires self-reported cigarettes per day.
Outcome measures
| Measure |
Combination NRT and Counseling
n=265 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=262 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=261 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
n=788 Participants
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
0 week
|
2.50 cigarettes per day
Standard Error 0.38
|
2.95 cigarettes per day
Standard Error 0.32
|
3.74 cigarettes per day
Standard Error 0.38
|
3.06 cigarettes per day
Standard Error 0.21
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
1 week
|
3.06 cigarettes per day
Standard Error 0.40
|
3.18 cigarettes per day
Standard Error 0.34
|
4.46 cigarettes per day
Standard Error 0.37
|
3.56 cigarettes per day
Standard Error 0.22
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
2 week
|
3.43 cigarettes per day
Standard Error 0.39
|
3.08 cigarettes per day
Standard Error 0.35
|
5.00 cigarettes per day
Standard Error 0.41
|
3.83 cigarettes per day
Standard Error 0.22
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
4 week
|
4.08 cigarettes per day
Standard Error 0.43
|
3.63 cigarettes per day
Standard Error 0.41
|
5.79 cigarettes per day
Standard Error 0.43
|
4.49 cigarettes per day
Standard Error 0.25
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
12 week
|
6.38 cigarettes per day
Standard Error 0.53
|
5.75 cigarettes per day
Standard Error 0.50
|
8.33 cigarettes per day
Standard Error 0.52
|
3.50 cigarettes per day
Standard Error 0.30
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
26 week
|
7.68 cigarettes per day
Standard Error 0.58
|
7.09 cigarettes per day
Standard Error 0.53
|
9.38 cigarettes per day
Standard Error 0.57
|
8.03 cigarettes per day
Standard Error 0.32
|
|
Longitudinal Models of Smoking Quantity in Cigarettes Per Day Outcomes Across Multiple Time Points.
52 week
|
7.67 cigarettes per day
Standard Error 0.59
|
7.76 cigarettes per day
Standard Error 0.57
|
8.98 cigarettes per day
Standard Error 0.55
|
8.12 cigarettes per day
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Pre-quit week to Week 12Population: Not all participants were evaluable for this outcome measure due to data not being available. Also the Varenicline (Chantix) and Counseling Arm did not receive the lozenge or the patch. The Combination NRT and Counseling Arm did not receive Varenicline (Chantix)
Adherence is the proportion of expected medication (varenicline, patch, lozenge) taken as advised during pre-quit week to week 12
Outcome measures
| Measure |
Combination NRT and Counseling
n=234 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=242 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=233 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Medication Adherence
Patch
|
0.65 proportion of expected medication taken
Standard Deviation 0.34
|
—
|
0.57 proportion of expected medication taken
Standard Deviation 0.36
|
—
|
|
Medication Adherence
Lozenge
|
0.57 proportion of expected medication taken
Standard Deviation 0.39
|
—
|
0.57 proportion of expected medication taken
Standard Deviation 0.38
|
—
|
|
Medication Adherence
Varenicline (Chantix)
|
—
|
0.67 proportion of expected medication taken
Standard Deviation 0.32
|
0.70 proportion of expected medication taken
Standard Deviation 0.35
|
—
|
SECONDARY outcome
Timeframe: Pre-quit week to Week 12Population: Not all participants were evaluable for this outcome measure due to data not being available.
All reported side effects (occurring\>4%) will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as rate of occurrence during the period of medication use.
Outcome measures
| Measure |
Combination NRT and Counseling
n=229 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=241 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=208 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Side Effects
Racing Heart
|
27 Participants
|
24 Participants
|
17 Participants
|
—
|
|
Side Effects
Nausea
|
53 Participants
|
92 Participants
|
59 Participants
|
—
|
|
Side Effects
Vomiting
|
28 Participants
|
36 Participants
|
27 Participants
|
—
|
|
Side Effects
Headache
|
81 Participants
|
81 Participants
|
71 Participants
|
—
|
|
Side Effects
Sleep Disturbance
|
49 Participants
|
55 Participants
|
42 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-quit, quit, week 1, week 2, and week 4Population: Not all participants were evaluable for this outcome measure due to data not being available.
* Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS), there are 28 items. * Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal. * The scores were calculated by averaging a mean score of each item for each participant with data from time point pre-quit, quit, week 1, week 2, and week 4. The mean score for each participant was averaged for each item and a mean score was taken for each treatment condition (cNRT, Varenicline, Placebo). These data are reported as mean withdrawal scores and not change in withdrawal scores.
Outcome measures
| Measure |
Combination NRT and Counseling
n=261 Participants
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=263 Participants
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=253 Participants
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
3 Arms Combined
This is the total of all participants who were enrolled in all 3 arms including Combination NRT and Counseling, Varenicline (Chantix) and Counseling, and Placebo Medicine and Counseling.
|
|---|---|---|---|---|
|
Withdrawal
Anger
|
1.33 score on a scale
Standard Deviation 0.75
|
1.49 score on a scale
Standard Deviation 0.81
|
1.47 score on a scale
Standard Deviation .79
|
—
|
|
Withdrawal
Anxiety
|
1.69 score on a scale
Standard Deviation 0.79
|
1.81 score on a scale
Standard Deviation 0.90
|
1.82 score on a scale
Standard Deviation 0.83
|
—
|
|
Withdrawal
Concentration
|
1.28 score on a scale
Standard Deviation 0.64
|
1.48 score on a scale
Standard Deviation 0.76
|
1.42 score on a scale
Standard Deviation 0.76
|
—
|
|
Withdrawal
Craving
|
2.29 score on a scale
Standard Deviation 0.85
|
2.20 score on a scale
Standard Deviation 0.86
|
2.50 score on a scale
Standard Deviation 0.83
|
—
|
|
Withdrawal
Hunger
|
2.11 score on a scale
Standard Deviation 0.84
|
2.28 score on a scale
Standard Deviation 0.80
|
2.17 score on a scale
Standard Deviation 0.79
|
—
|
|
Withdrawal
Sadness
|
1.01 score on a scale
Standard Deviation 0.63
|
1.11 score on a scale
Standard Deviation 0.69
|
1.11 score on a scale
Standard Deviation 0.61
|
—
|
|
Withdrawal
Sleep
|
1.49 score on a scale
Standard Deviation 0.82
|
1.70 score on a scale
Standard Deviation 0.89
|
1.54 score on a scale
Standard Deviation 0.92
|
—
|
Adverse Events
Combination NRT and Counseling
Serious events: 23 serious events
Other events: 193 other events
Deaths: 3 deaths
Varenicline (Chantix) and Counseling
Serious events: 17 serious events
Other events: 204 other events
Deaths: 2 deaths
Placebo Medicine and Counseling
Serious events: 27 serious events
Other events: 175 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Combination NRT and Counseling
n=275 participants at risk
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 participants at risk
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 participants at risk
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Stage 4 endometriosis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Death due to cardiorespiratory arrest
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Death due to congestive heart failure
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Heart failure
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Left bundle branch block
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Endocrine disorders
Death due to diabetic coma
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Endocrine disorders
Diabetic ketoacidosis
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Endocrine disorders
Hyperthyroidism
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Endocrine disorders
Type 2 Diabetes
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Diverticulosis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.73%
2/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Hemorrhoid
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
General disorders
Death, unknown
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
General disorders
Death due to natural causes
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Hepatobiliary disorders
Ammonia poisoning of liver
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Antibiotic spacer for MRSA infection in knee
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Cellulitis, right hand
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Ear infection
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Surgical incision site infection (post-surgery)
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Infection of second toe on left foot
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Influenza
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
MRSA infection in knee
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Malaria
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Severe sinus infection
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Infections and infestations
Severe tooth infection
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Broken arm
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Broken collarbone
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Broken ribs
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Cervical disc fracture
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Complication from gastric bypass surgery
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Death due to heroin overdose
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Gunshot wound
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Homicide by gunshot
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Motor vehicle accident (injury of intervertebral discs T10-12)
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Partial amputation of leg due to MRSA infection
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Struck by vehicle
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Injury, poisoning and procedural complications
Sternum fracture
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Musculoskeletal and connective tissue disorders
Inter-vertebral dis herniation
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to Lung cancer
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to brain tumor complications
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer (stage 4)
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Multiple sclerosis
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Seizure
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Stroke
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Alcohol dependence
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Anxiety
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Bipolar depression
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Unspecified mood disorder
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Renal and urinary disorders
Death due to kidney failure
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic episode
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
1.1%
3/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic sinus necrosis
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.73%
2/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic outlet syndrome
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing due to COPD
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Abdominal hysterectomy due to endometriosis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Foot surgery to fix broken toes on right foot
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Hip replacement surgery
|
0.73%
2/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Hysterectomy due to cervical cancer
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Hysterectomy due to enlarged fallopian tubes
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Knee surgery for osteoarthritis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Left knee replacement
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Minor procedure to clean wound on right foot
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Surgery for aortic valve stenosis and cardiac bypass
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Surgical and medical procedures
Urethral sling surgery due to urinary incontinence
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Vascular disorders
Abdominal aortic aneurysm
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.36%
1/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Vascular disorders
Hypertension
|
0.00%
0/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Vascular disorders
Pulmonary embolism
|
0.36%
1/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.00%
0/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
0.37%
1/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
Other adverse events
| Measure |
Combination NRT and Counseling
n=275 participants at risk
Combination Nicotine replacement therapy (cNRT) (patch and lozenge) and smoking cessation counseling will be provided to participants. Lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
Varenicline (Chantix) and Counseling
n=274 participants at risk
Varenicline (pill) and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Seven smoking cessation counseling sessions will be given during treatment.
|
Placebo Medicine and Counseling
n=273 participants at risk
Placebo pill and smoking cessation counseling will be provided to participants for 12 weeks with 1 week pre-quit titration. Placebo lozenges will be given for 12 weeks with a 1 week pre-quit titration and patch for 12 weeks. Seven smoking counseling sessions will be given during treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
19.3%
53/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
33.6%
92/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
21.6%
59/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Vomiting
|
10.2%
28/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
13.1%
36/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
9.9%
27/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Headache
|
29.5%
81/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
29.6%
81/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
26.0%
71/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Rapid, slow, pounding, or irregular heartbeat
|
9.8%
27/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.8%
24/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
6.2%
17/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Insomnia
|
17.8%
49/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
20.1%
55/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
15.4%
42/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Vivid dreams
|
22.9%
63/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
36.5%
100/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
22.0%
60/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Nervous system disorders
Dizziness
|
14.9%
41/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
19.0%
52/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
14.3%
39/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
General disorders
Weakness
|
9.1%
25/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
11.7%
32/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
11.7%
32/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Skin and subcutaneous tissue disorders
Sweating
|
16.7%
46/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
14.6%
40/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
10.6%
29/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Skin and subcutaneous tissue disorders
Itching/hives
|
12.7%
35/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
10.6%
29/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
5.9%
16/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
33/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
6.6%
18/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.1%
22/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Immune system disorders
Swelling in face or hands
|
5.5%
15/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
3.6%
10/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
5.9%
16/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Immune system disorders
Swelling or tingling in mouth or throat
|
7.3%
20/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
2.9%
8/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
4.4%
12/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Mouth problems (e.g. pain or sore)
|
7.6%
21/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
7.3%
20/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
7.7%
21/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Gastrointestinal disorders
Indigestion
|
14.9%
41/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
18.6%
51/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
13.2%
36/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.4%
34/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
15.7%
43/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.1%
22/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Cardiac disorders
Chest tightness
|
8.7%
24/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.8%
24/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
5.9%
16/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Respiratory, thoracic and mediastinal disorders
Trouble breathing
|
5.8%
16/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
7.7%
21/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.1%
22/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Feeling worried, nervous, scared, or anxious
|
18.2%
50/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
23.4%
64/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
21.2%
58/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Feeling panicky or having panic attacks
|
8.0%
22/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.4%
23/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.1%
22/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Feeling agitated and restless
|
17.1%
47/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
20.4%
56/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
15.8%
43/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Feeling hostile or angry towards others
|
5.5%
15/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
11.7%
32/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
8.4%
23/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
|
Psychiatric disorders
Feeling significantly down, depressed, or hopeless
|
17.1%
47/275 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
21.2%
58/274 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
16.1%
44/273 • Adverse events were collected until from enrollment until 1 year post target quit date. Post-study adverse events will be recorded when the subject volunteers to report such events to the investigator team.
Adverse events are assessed in each follow-up visit to the end of the trial. With respect to the pharmacotherapy, participants will be made aware of the common side effects before they consent to participate in the study. During each study visit, participants are asked about common side effects associated with the drug(s) as well as any other symptoms participants report regardless of attribution to the drug(s).
|
Additional Information
Li-Shiun Chen, M.D.
Washington University School of Medicine
Phone: 314-362-3932
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place